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Endoluminal stenting for benign colonic obstruction R. Davidson, W. B. Sweeney University of Massachusetts Medical Center, Department of Surgery, 55 Lake Avenue North, Worcester, MA 01655, USA Received: 10 June 1997/Accepted: 1 July 1997 Abstract. We report a case of complete descending colon obstruction due to diverticular disease that was initially managed by endoscopic stent placement followed by single- stage left colectomy with primary anastomosis. Traditional management of complete large bowel obstruction, whether due to benign or malignant disease, most often requires a temporary colostomy because of unprepared colon. In this case, preparation of the colon was accomplished by suc- cessful stenting of the benign colonic obstruction. We be- lieve that endoscopic colonic stenting is an effective way of avoiding a temporary colostomy in patients with complete large bowel obstruction. Key words: Large bowel obstruction — Colonic stent — Endoprosthesis — Diverticular stricture The surgical management of colonic obstruction, regardless of its nature, is always a dilemma. Particular challenging are those lesions of the left colon and rectosigmoid region. Both diverticular disease and cancer affect this area of the colon frequently. Management has traditionally been surgical, in- cluding excision of the obstructing lesion and diversion of the fecal stream. A second procedure may eventually restore colonic continuity. This sequence of events, initiated by emergency exploration, often leads to increased morbidity and mortality [2]. Recently some investigators of malignant disease in the rectosigmoid colon have advocated the use of endoluminal stents to acutely decompress the bowel and avoid major surgery [7]. These stents have proven successful according to several published reports. We describe a case of colonic stenting for benign disease of the colon. Case report A 60-year-old woman with a history of hypertension and hypercholester- olemia was seen by her primary care physician for complaints of obstipa- tion over a period of 1–2 months. She suffered from intermittent diffuse abdominal pain with bloating and occasional nausea and vomiting. She had also lost 15 lb in 1 month. Surgical consultation was obtained after an abdominal radiograph revealed a large bowel obstruction (Fig. 1). At the time of admission, her abdomen was notably distended but not tender. There was some hyerresonance on percussion but no evidence of a mass. She had no fever, and her white blood cell count and hematocrit were normal. She subsequently underwent a limited barium enema that demon- strated circumferential annular constriction of the descending colon with near total obstruction to retrograde flow (Fig. 2). After a frank discussion, the patient agreed to undergo colonic stenting in an attempt to achieve bowel decompression. The day following her admission, she underwent endoluminal stenting using both endoscopic and fluoroscopic guidance. The colonoscope was first passed to the distal point of the colonic stricture, which was at the descending to sigmoid colon junction. A guide wire was then placed through the stricture into the proximal dilated bowel under both fluoroscopic and endoscopic guidance. A catheter was placed over the guide wire, and a small amount of contrast was injected to accurately define the length of the stricture. The catheter was withdrawn and the guide wire left in place. Finally, two overlapping Wallstent enteral endoprostheses (Pfizer/Schneider, Minneapolis, MN 55442, USA) were introduced. A 22 × 60 mm stent was overlapped with a 22 × 90 mm stent in order to completely bridge the stricture (Fig. 3). After the deployment of both of these colonic stents in an overlapping fashion, immediate bowel decompression was achieved. Endoscopic evalu- ation of the stented colonic stricture was performed (Fig. 4). The patient tolerated the procedure well. Over the next few days, she underwent gradual colonic cleansing. On the 6th day following her stenting procedure, she underwent left colectomy with primary anastomosis (Fig. 5). The postoperative course was uneventful and she was discharged home on postoperative day 4, tolerating a regular diet and having formed bowel movements. The histopathology revealed diverticulitis with stricture of the left colon. Discussion Endoscopic stenting of gastrointestinal strictures is not new. With advances in technology, the relatively limited role of endoscopically placed stents has expanded. Initially, endo- scopic stenting was confined to the biliary tree, but recent innovations have expanded its role in both esophageal and colorectal disease. The initial colonic stents described were often crude, made of plastic, and associated with potential complications such as perforation and displacement of the stent [6]. Newer technology has expanded the role of stents in the colon and rectum. These self-expanding stents can now be passed through a typical colonoscopic channel. There are a considerable number of reports that describe stenting for malignant disease of the colon and rectum with Correspondence to: W. B. Sweeney Surg Endosc (1998) 12: 353–354 © Springer-Verlag New York Inc. 1998

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April 1998 dugaar

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Endoluminal stenting for benign colonic obstruction

R. Davidson, W. B. Sweeney

University of Massachusetts Medical Center, Department of Surgery, 55 Lake Avenue North, Worcester, MA 01655, USA

Received: 10 June 1997/Accepted: 1 July 1997

Abstract. We report a case of complete descending colonobstruction due to diverticular disease that was initiallymanaged by endoscopic stent placement followed by single-stage left colectomy with primary anastomosis. Traditionalmanagement of complete large bowel obstruction, whetherdue to benign or malignant disease, most often requires atemporary colostomy because of unprepared colon. In thiscase, preparation of the colon was accomplished by suc-cessful stenting of the benign colonic obstruction. We be-lieve that endoscopic colonic stenting is an effective way ofavoiding a temporary colostomy in patients with completelarge bowel obstruction.

Key words: Large bowel obstruction — Colonic stent —Endoprosthesis — Diverticular stricture

The surgical management of colonic obstruction, regardlessof its nature, is always a dilemma. Particular challenging arethose lesions of the left colon and rectosigmoid region. Bothdiverticular disease and cancer affect this area of the colonfrequently. Management has traditionally been surgical, in-cluding excision of the obstructing lesion and diversion ofthe fecal stream. A second procedure may eventually restorecolonic continuity. This sequence of events, initiated byemergency exploration, often leads to increased morbidityand mortality [2].

Recently some investigators of malignant disease in therectosigmoid colon have advocated the use of endoluminalstents to acutely decompress the bowel and avoid majorsurgery [7]. These stents have proven successful accordingto several published reports. We describe a case of colonicstenting for benign disease of the colon.

Case report

A 60-year-old woman with a history of hypertension and hypercholester-olemia was seen by her primary care physician for complaints of obstipa-

tion over a period of 1–2 months. She suffered from intermittent diffuseabdominal pain with bloating and occasional nausea and vomiting. She hadalso lost 15 lb in 1 month. Surgical consultation was obtained after anabdominal radiograph revealed a large bowel obstruction (Fig. 1).

At the time of admission, her abdomen was notably distended but nottender. There was some hyerresonance on percussion but no evidence of amass. She had no fever, and her white blood cell count and hematocrit werenormal. She subsequently underwent a limited barium enema that demon-strated circumferential annular constriction of the descending colon withnear total obstruction to retrograde flow (Fig. 2).

After a frank discussion, the patient agreed to undergo colonic stentingin an attempt to achieve bowel decompression. The day following heradmission, she underwent endoluminal stenting using both endoscopic andfluoroscopic guidance. The colonoscope was first passed to the distal pointof the colonic stricture, which was at the descending to sigmoid colonjunction. A guide wire was then placed through the stricture into theproximal dilated bowel under both fluoroscopic and endoscopic guidance.A catheter was placed over the guide wire, and a small amount of contrastwas injected to accurately define the length of the stricture. The catheterwas withdrawn and the guide wire left in place. Finally, two overlappingWallstent enteral endoprostheses (Pfizer/Schneider, Minneapolis, MN55442, USA) were introduced. A 22 × 60 mm stent was overlapped witha 22 × 90 mm stent in order to completely bridge the stricture (Fig. 3).After the deployment of both of these colonic stents in an overlappingfashion, immediate bowel decompression was achieved. Endoscopic evalu-ation of the stented colonic stricture was performed (Fig. 4).

The patient tolerated the procedure well. Over the next few days, sheunderwent gradual colonic cleansing. On the 6th day following her stentingprocedure, she underwent left colectomy with primary anastomosis (Fig.5). The postoperative course was uneventful and she was discharged homeon postoperative day 4, tolerating a regular diet and having formed bowelmovements. The histopathology revealed diverticulitis with stricture of theleft colon.

Discussion

Endoscopic stenting of gastrointestinal strictures is not new.With advances in technology, the relatively limited role ofendoscopically placed stents has expanded. Initially, endo-scopic stenting was confined to the biliary tree, but recentinnovations have expanded its role in both esophageal andcolorectal disease. The initial colonic stents described wereoften crude, made of plastic, and associated with potentialcomplications such as perforation and displacement of thestent [6]. Newer technology has expanded the role of stentsin the colon and rectum. These self-expanding stents cannow be passed through a typical colonoscopic channel.

There are a considerable number of reports that describestenting for malignant disease of the colon and rectum withCorrespondence to:W. B. Sweeney

Surg Endosc (1998) 12: 353–354

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good results [1, 3–5, 7]. We describe a case in which abenign colonic stricture was successfully stented. If stentingcan be associated with low morbidity, then the ability tostent preoperatively allowing for decompression and bowelpreparation would be preferable to proceeding with a two-stage procedure. Certainly in patients who have debilitatingcomorbid factors, it would be beneficial to avoid two op-erations for benign disease.

Conclusions

We believe that endoscopic stenting is a relatively easy andeffective method for decompressing the colon in both be-nign and malignant obstruction. Endoluminal stenting formalignant as well as benign colonic obstruction should leadto substantial decrease in the morbidity and mortality asso-ciated with this disease, as well as reducing the cost oftreatment.

References

1. Canon CL, Baron TH, Morgan DE, Dean PA, Koehler RE (1997) Treat-ment of colonic obstruction with expandable metal stents: radiologicfeatures. Am J Roentgen 168: 199–205

2. Leitman IM, Sullivan JD, Brams D, DeCosse JJ (1992) Multivariateanalysis of morbidity and mortality from the initial surgical manage-ment of obstructing of the colon. Surg Gynecol Obstet 174: 513–518

3. Mainar A, Tejero E, Maynar M, Ferral H, Kastaneda-Zuniga W (1996)Colorectal obstruction: treatment with metallic stents. Radiology 198:761–764

4. Raijman I, Siemans M, Marcon N (1995) Use of an expandable ultraflexstent in the treatment of malignant rectal stricture. Endoscopy 27: 273–276

5. Rey JF, Romanczyk T, Greff M (1995) Metallic stents for palliation ofrectal carcinoma: a preliminary report on twelve patients. Endoscopy27: 501–504

6. Rupp KD, Dohmoto M, Meffert R, Holzgreve A, Hohlbach G (1995)Cancer of the rectum-palliative endoscopic treatment. Eur J Surg Oncol21: 644–647

7. Tejero E, Fernandez-Lobato R, Mainar A, Montes C, Pinto I, FernandezL, Jorge E, Lozano R (1997) Initial results of a new procedure fortreatment of malignant obstruction of the left colon. Dis Colon Rectum40: 432–436

Fig. 1. Abdominal radiograph demonstrating large bowel obstruction.

Fig. 2. Barium enema examination revealing a circumferential anular stricture of the descending colon.

Fig. 3. Abdominal radiograph demonstrating two overlapped metallic stents in good position with decompression of the colonic obstruction.

Fig. 4. Endoscopic evaluation of the stented colonic stricture.

Fig. 5. Left colectomy specimen opened, revealing the preoperatively placed endoluminal metallic stent.

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The effect of peritoneal air exposure on postoperative tumor growth

J. C. Southall, S. W. Lee, M. Bessler, J. D. Allendorf, R. L. Whelan

Columbia University College of Physicians and Surgeons, Columbia Presbyterian Medical Center, Department of Surgery, 161 Fort WashingtonAvenue, New York, NY 10032, USA

Received: 14 May 1997/Accepted: 14 July 1997

AbstractBackground:Previous work has demonstrated that cell-mediated immune function is better preserved in rodentsafter laparoscopic than open surgery. The cause of this lap-arotomy-related immunosuppression is unclear. Some in-vestigators have attributed it to the length of the incision;others, to peritoneal air exposure. It has also been shownthat tumors in mice are more easily established and growlarger after sham laparotomy than after pneumoperitoneum.Lastly, the differences in tumor growth have been shown tobe, at least in part, attributable to the immunosuppressionthat occurs after laparotomy. The purpose of this study wasto determine if air pneumoperitoneum, presumably via im-munosuppression related to peritoneal air exposure, is as-sociated with increased tumor growth in the postoperativeperiod.Methods:A total of 150 immunocompetent syngeneic micereceived high-dose intradermal injections of mouse mam-mary carcinoma tumor cells. They were then randomized toundergo one of the following procedures: (a) anesthesiaalone, (b) air insufflation (4–6 mm Hg), (c) CO2 insuffla-tion, or (d) full laparotomy. No intraabdominal procedurewas carried out. All procedures were 20 min long. After 12days, the animals were killed and the mean tumor massdetermined for each group.Results:All animals grew tumors. There was no significantdifference in the mean tumor size of the anesthesia control,CO2 insufflation, and air insufflation groups (p > 0.85 byANOVA). However, the laparotomy group tumors were 1.5times as large as those of the other three groups (p < 0.05 byANOVA).Conclusions:In this model, air insufflation did not signifi-cantly affect postoperative tumor growth, nor did CO2 pneu-moperitoneum. However, full laparotomy was associatedwith increased tumor growth.

Key words: Laparoscopy — CO2 pneumoperitoneum —Pneumoperitoneum — Tumor growth

The introduction, development, and growth of laparoscopictechniques in general surgery has proceeded at an amaz-ingly rapid rate. The purported clinical benefits of mini-mally invasive surgery include less postoperative pain,more rapid resumption of diet, and shorter hospitalization[5–8]. The physiologic basis of these benefits remains, forthe most part, obscure. Few basic science studies had beendone prior to the laparoscopic explosion that occurred in theearly 1990s. Over the last 6 years, our laboratory and othershave been attempting to elucidate the physiologic, immu-nologic, and oncologic impact of the laparoscopic and openmethods of abdominal exposure.

In both large and small animal models, it has been es-tablished that cell-mediated immune function, as measuredby serial delayed-type hypersensitivity (DTH) testing, issignificantly better preserved after pneumoperitoneum andlaparoscopic bowel resection than after laparotomy andopen resection [2, 10]. Because the diminished DTH re-sponse observed after laparotomy is not seen after mini-laparotomy, it has been hypothesized that immune functiondifferences are related to incision length [3]. Watson et al.,who studied other indicators of immune function, alsofound that laparotomy resulted in immunosuppression [12].However, they concluded that the exposure of the peritonealcavity to lipopolysaccharides found in circulating air is thereason for the postoperative immunosuppression.

In a separate series of murine studies, Allendorf et al.have shown that tumors are more easily established andgrow more rapidly after laparotomy and open bowel resec-tion than after pneumoperitoneum and laparoscopic bowelresection [1, 4]. Finally, in an experiment involving T-celldeficient mice, the tumor growth differences have beendemonstrated to be attributable in large part to the immu-nosuppression that occurs after laparotomy [4].

The purpose of this study was to assess and comparetumor growth following air pneumoperitoneum, CO2 pneu-

Presented at the annual meeting of the Society of American Gastrointes-tinal Endoscopic Surgeons (SAGES), San Diego, California, USA, 20–21March 1997Correspondence to:R. L. Whelan

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moperitoneum, and laparotomy. If, in fact, it is exposure ofthe peritoneal cavity to air and not the incision that causesthe immunosuppression seen after laparotomy, then tumorgrowth should be increased after air pneumoperitoneum.

Materials and methods

The protocol for this study was approved by the Columbia UniversityInstitutional Animal Care and Use Committee in accordance with FDAregulations. All animals were acclimated to a climate- and light cycle–controlled environment for$24 h prior to investigations. Mice were fedstandard laboratory rodent chow and tap water ad libitum.

The mouse mammary carcinoma (MMC) tumor cell line was utilizedfor this study. This tumor line is derived from the MC2 cell line [11]obtained from Dr. J. Vaage at the Roswell Park Cancer Institute (Buffalo,NY, USA). MMC is an immunogenic cell line that shows a growth plateau12–14 days after tumor cell inoculation, after which#20% of tumors beginto spontaneously regress. MMC is syngeneic to the C3H/He mouse strain.This is an immunocompetent strain. It has been established in previousexperiments that after an intradermal injection of one million tumor cells,>95% of control mice develop tumors [1].

On the day of operative intervention, tumor cells were prepared as asingle-cell suspension for intradermal inoculation. MMC cells growingfree-floating in RPMI 1640 medium supplemented with 10% fetal calfserum, 150 U/ml penicillin, and 150 mg/ml streptomycin were washedtwice, counted, and resuspended in phosphate-buffered saline. A suspen-sion of 107 cells per ml was prepared and mice were injected with 0.1 ml,for a total inoculum of 106 cells. Tumor cell viability throughout theexperiment was determined to be >95% by trypan blue exclusion.

A total of 150 5–6 week old female C3H/He mice (Charles RiverLaboratories, Wilmington, MA, USA) were used in this study. On the dayof and prior to the intervention, the mice were restrained, shaved, and thengiven an intradermal injection of 0.1 ml of the tumor cell suspension (107

cells/ml) in the dorsal skin. Animals were then randomly assigned to oneof the following four groups: (a) anesthesia control, (b) CO2 pneumoperi-toneum, (c) air pneumoperitoneum, and (d) laparotomy. Immediately be-fore the procedure, all animals were anesthetized by intraperitoneal injec-tion of ketamine (50 mg/kg) and xylazine (5 mg/kg) in a total volume of0.3 ml.

Anesthesia control mice underwent no procedure and after 20 min werereturned to their cages. In both air and CO2 pneumoperitoneum groups,insufflation was accomplished via an 18-gauge angiocath inserted into theabdomen. A pressure of 4–6 mm Hg was maintained for 20 min in eachgroup. In the air pneumoperitoneum group, insufflation was carried outwith ambient room air. Laparotomy group animals underwent a ziphoid topubic symphisis midline incision that was stapled closed in one layer at 20min. The animals were killed and the tumors excised and weighed onpostoperative day 12. Representative tumor samples were taken from eachgroup. The presence of tumor was confirmed via histologic sections evalu-ated by a pathologist. All data were collected in a blinded fashion. Differ-ences among groups were analyzed for statistical significance by ANOVA.

Results

Tumor nodules developed in all mice by postoperative day12. The mean tumor size (62.2 ± 52 mg) of the laparotomygroup was 1.5 times larger than the control (40.3 ± 39 mg),CO2 insufflation (39.5 ± 43 mg), and air insufflation groups(37.9 ± 34 mg) (p < 0.05 for all comparisons). There wereno significant differences in tumor mass between the CO2air, and anesthesia groups (p > 0.85 for all comparisons).The mortality of the study procedure was 2%.

Discussion

Rat DTH studies from our laboratory have established thatcell-mediated immune function is better preserved after lap-

aroscopic procedures than after the equivalent open proce-dures carried out via a full-length midline laparotomy inci-sion [7]. Interestingly, significant immunosuppression wasnot found when a sham mini-laparotomy (one-half the zi-phoid to pubis distance) was compared to pneumoperito-neum [3]. This finding suggested that the immunosuppres-sion observed following a full laparotomy was related to thelength of the incision.

Watson et al., who looked at different indicators of im-mune function in a mouse model, have also shown thatimmunosuppression occurs after laparotomy [12]. They be-lieve that this immunosuppression is related to factors incirculating air that cause lipopolysaccharide (LPS) translo-cation across the gut wall, which in turn has a systemiceffect on the immune system. Therefore, they believe thatperitoneal exposure to air—not the incision length—is thecause of the documented differences in immune functionthat occur after laparotomy.

Previous work from our laboratory, utilizing three dif-ferent tumor cell lines, has also demonstrated that tumors inmice are more easily established and grow larger after lap-arotomy and open bowel resection than after pneumoperi-toneum and laparoscopic bowel resection [1, 9]. Further-more, in an experiment involving athymic mice, it has beenestablished that these tumor growth differences are, at leastin part, related to the immunosuppression that occurs afterlaparotomy [4]. Whereas tumors grew larger after laparot-omy in immunocompetent mice, in athymic mice (without Tcells) the open and pneumoperitoneum group tumors wereof equal size.

If peritoneal air exposure is the cause of the immuno-suppression seen after laparotomy and if this immunosup-pression results in more rapid tumor growth, then tumorsthat develop after air insufflation should be larger than thoseafter CO2 pneumoperitoneum. The current study was de-signed to test this hypothesis. Utilizing the C3H/He mousestrain and the MMC tumor cell line, insufflation with roomair was compared to pneumoperitoneum with CO2, laparot-omy, and anesthesia alone. A high dose of tumor cells wasinjected intradermally immediately prior to the surgical in-tervention.

As expected, tumors were found in all animals 12 daysfollowing the test procedures. There was no difference inthe mean tumor size of the air, CO2, and anesthesia controlgroups (p < 0.85 for all comparisons) (Fig. 1). However, the

Fig. 1. Tumor mass by postoperative day 12 after air insufflation, CO2

insufflation, and laparotomy. *p < 0.05 for CO2, air, and control groupsversus laparotomy. **p value not significant for air versus control, airversus CO2, CO2 versus control.

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laparotomy group tumors were 1.5 times larger than those ofthe other three groups (p < 0.05). These findings are similarto those of an earlier study from our laboratory [1]. Ourresults suggest that while peritoneal air exposure does notsignificantly affect the rate of postoperative tumor growth,a full laparotomy incision is associated with larger tumors.

This does not necessarily mean that peritoneal air expo-sure does not have immunomodulating effects. It is possiblethat peritoneal air exposure and a full laparotomy incisioninfluence the immune system in different ways via separatepathways. If this is the case, then the immunosuppressionrelated to a large incision is associated with increased post-operative tumor growth, whereas that related to air exposureis not. Our laboratory is presently studying the impact oflarge abdominal incisions and air exposure on lymphocyteproliferation rates in a murine model.

Acknowledgment:This investigation was made possible by generous sup-port from the Ethicon division of Johnson and Johnson Corporation and theUnited States Surgical Corporation.

References

1. Allendorf JDF, Bessler M, Kayton ML, Oesterling SD, Trear MR,Nowygrod R, Whelan RL (1995) Increased tumor establishment andgrowth after laparotomy versus laparoscopy in a murine model. ArchSurg 130: 649–653

2. Allendorf JDF, Bessler M, Whelan RL, Trokel M, Laird DA, TerryMB, Treat MR (1996) Better preservation of immune function afterlaparoscopic-assisted vs. open bowel resection in a murine model. DisColon Rectum 39s: S67–72

3. Allendorf JDF, Bessler M, Whelan RL, Trokel M, Laird DA, TerryMB, Treat MR (1996) Postoperative immune function varies inverselywith the degree of surgical trauma. Surg Endosc 11: 427–430

4. Allendorf JDF, Marvin MR, Bessler M, Whelan RL (1996) Tumorsgrow larger after laparotomy vs laparoscopy in immunocompetentmice but not in athymic mice. Surg Forum 47: 150–152

5. Barkun JS, Barkun AN, Sampalis JS, Fried G, Taylor B, Wexler MJ,Goresky CA, Meakins JL (1992) Randomised controlled trial of lap-aroscopic versus mini cholecystectomy. Lancet 340: 1116–1119

6. Gadacz TR, Talamini MA (1991) Traditional versus laparoscopic cho-lecystectomy. Am J Surg 161: 336–338

7. Grace PA, Quereshi A, Coleman J, Keane R, McEntee G, Broe P,Osborne H, Bouchier-Hayes D (1991) Reduced postoperative hospi-talization after laparoscopic cholecytectomy. Br J Surg 78: 160–162

8. Reddick EJ, Olsen DO (1989) Laparoscopic laser cholecystectomy.Surg Endosc 3: 131–133

9. Southall JC, Lee SW, Allendorf JDF, Bessler M, Whelan RL (1997)Colon adenocarcinoma and B-16 melanoma grow larger after laparot-omy versus laparoscopy in a murine model [Abstract]. Dis ColonRectum 40: A20

10. Trokel MJ, Bessler M, Treat MR, Whelan RL, Nowygrod R (1994)Preservation of immune response after laparoscopy. Surg Endosc 8:1385–1387

11. Vaage J, Pepin K (1985) Morphological observations during develop-ing concomitant immunity against a C3H/He mammary tumor. CancerRes 45: 659–666

12. Watson RW, Redmond HP, McCarthy J, Bouchier-Hayes D (1995)Exposure of the peritoneal cavity to air regulates early inflammatoryresponses to surgery in a murine model. Br J Surg 82: 1060–1065

Discussion

Dr. Talamini: In Baltimore, as I’m sure in many commu-nities across the country, there is the belief that when apatient with cancer has air touch the tumor that it suddenlyexplodes in growth, and I guess this, perhaps, can finally putthat theory to rest.

Dr. Marcus: How did you come up with the time of 12days? Do you think that some of the effect of not having adifference between your air and CO2 might just be theamount of time for your cell-mediated response?

Dr. Southall: Actually, the 12 days is a time point wheretumor growth is at its maximum, and where differences willbe maximized. Beyond 12 days, there is a growth plateau, atwhich point differences will be minimized, essentially.

Dr. Nduka: I’d like to congratulate you and your group foryour excellent work in this field, this complicated field ofoncological laparoscopy. My question is concerning yourmodel. Do you think it is appropriate to use an intradermalmodel for studying what, in effect, is an intraperitonealproblem?

Dr. Southall:Well, we were studying the effects of carbondioxide gas and air gas. Insufflation is associated with twoprocesses: (1) a direct process of insufflation gas and pres-sure on a tumor, intraperitoneal tumor, and (2) on systemiceffect of carbon dioxide or air gas. This model focuses onthe systemic effect, and for that reason the tumor is placedin a position where it is not directly exposed to the gases.

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Case reports

Operative technique for thoracoscopic transmyocardiallaser revascularization

A. Pietrabissa,1 A. Milano,2 U. Bortolotti, 2 F. Mosca1

1 Istituto di Chirurgia Generale e Sperimentale, Universita` di Pisa, Ospedale di Cisanello, via Paradisa 2, 56124 Pisa, Italy2 Cardiochirurgia, Universita` di Pisa, Pisa, Italy

Abstract. We describe herein the operative steps used toperform a transmyocardial laser revascularization by thora-coscopy. A special technique and specific equipment arerequired for the efficacy and safety of the procedure. Ourpreliminary results with this novel approach suggest that itcould be a valid alternative to the thoracotomic procedure.

Key words: Myocardial revascularization — Laser surgery— Thoracoscopy

Transmyocardial laser revascularization (TMR) is a newapproach in the treatment of coronary artery disease forpatients deemed unsuitable for either angioplasty or bypassgrafting [1]. In this procedure, which is usually performedthrough a left anterior thoracotomy without cardiopulmo-nary bypass, a series of small transmural channels are cre-ated in reperfusable areas of the left ventricular wall of thebeating heart by repeated laser applications. The clinicalbenefit of TMR seems to be a consequence of the directperfusion of oxygenated blood from the left ventricle intothe myocardial vascular network. However, the exactmechanism by which cardiac perfusion is improved andangina relief is provided is not yet fully understood [2].

This report is based on our preliminary experience withTMR via the thoracoscopic approach in two patients. Itdetails the operative steps that we used to perform the pro-cedure.

Technique

Under general anesthesia with nonselective endotrachealventilation, the patient is placed in the right lateral decubitusposition with a 30° break of the operating table at the levelof the mid-thorax. A 25° angled telescope is advancedthrough a 10-mm port placed in the sixth intercostal space at

the posterior axillary line. A positive intrapleuric pressure of6 mm Hg is maintained by CO2 insufflation. Two operativetrocars are subsequently inserted: a 10-mm trocar in theseventh space at the anterior axillary line and another one inthe fourth intercostal space at the mid-axillary line. Thesecond trocar has a 5-mm flexible cannula to allow theintroduction of coaxially curved instruments (Storz, Tuttlin-gen, Germany) that will facilitate the safe opening of thepericardium.

A long pericardial incision is created anterior to the leftphrenic nerve with the use of graspers and coaxially curvedscissors. In cases where the patient has undergone previouscardiac surgery (usually through a mid-sternotomy), the ad-hesions between the left ventricle and the internal aspect ofthe pericardial sac are carefully divided. The superior edgeof the pericardial window is then suspended by two inter-rupted stitches to the anterior thoracic wall. Suturesmounted on 5-cm straight needles are used for this purpose.The straight needle is hand-driven percutaneously throughthe anterior thoracic wall until a sufficient length emergesfrom the pleural surface. The needle is then grasped inter-nally by a pair of needle holders. It is passed through thesuperior edge of the incised pericardium and then reversedand guided inside-out through the thoracic wall in the vi-cinity of the entrance point. The two ends of the suture aregrasped with a Kelly clamp and placed in gentle traction tomaximize the surgeon’s access to the left ventricle.

An average of 30 channels, 1 mm in diameter each, arethen created in the left ventricle by the tip of a holmiumlaser probe (Eclipse Surgical Technologies, Inc., Sunnyvale,CA, USA). This probe is advanced inside an Olsen’s chol-angiograsper (Storz) to reach the anterior and lateral epicar-dial surface of the left ventricle; it is then activated (Fig. 1).The base and the posterior aspect of the left ventricle areapproached with the aid of a specially designed right-angleapplicator, through which the flexible optical fiber of theholmium laser is easily advanced (Fig. 2). Bleeding fromthe epicardial holes created by laser application usuallystops spontaneously within a few minutes; occasionally,transient local compression is required. Compression is ex-erted by a peanut pledget holder inserted and retracted in-Correspondence to:A. Pietrabissa

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side a reducer tube. Finally, the pericardial incision is par-tially closed by approximating the cut edges with a fewinterrupted stitches to allow intrapleural drainage of peri-cardial fluid. A pleural aspiration drain is left and removed48 h later after pulmonary reexpansion.

Comment

A wide range of procedures can now be performed via thethoracoscopic approach, with a subsequent reduction in therequirement for postoperative analgesia and a shorter recov-ery period [3].

TMR is a simple operation currently indicated for pa-tients in whom conventional invasive methods of revascu-larization are no longer an option. Our early experience withthoracoscopic TMR in two patients indicates that this newapproach is feasible and safe. This technique provides agood alternative to the conventional thoracoscopic proce-dure, where the trauma of access constitutes the largestcomponent of total operative insult [4]. The fact that thesepatients tend to be elderly and chronically ill reinforces thepotential benefits of the minimally invasive approach toTMR in terms of recovery, short-term disability, and re-duced costs.

References

1. Horvath KA, Mannting F, Cummings N, Shernan SK, Cohn LH (1996)Transmyocardial laser revascularization: operative techniques andclinical results at two years. J Thorac Cardiovasc Surg 111: 1047–1053

2. Kohmoto T, Fisher PE, Gu A, Zhu SM, Yano OJ, Spotnitz HM, SmithCR, Burkhoff D (1996) Does blood flow through holmium: YAG trans-myocardial laser channels? Ann Thorac Surg 61: 861–868

3. Mulder DS (1993) Pain management principles and anesthesia tech-niques for thoracoscopy. Ann Thorac Surg 56: 630–632

4. Cushieri A (1995) Whither minimal access surgery: tribulations andexpectations. Am J Surg 169: 9–19

Fig. 1. Creation of transmyocardial channels on the lateral aspect of theleft ventricle by the holmium laser probe introduced inside the Olsen’scholangiograsper.

Fig. 2. The base of the left ventricle is reached with a specially designedright-angle applicator for the flexible fiber of the holmium laser.

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Spilled gallstones after laparoscopic cholecystectomy

A relevant problem? A retrospective analysis of 10,174 laparoscopic cholecystectomies

M. Schafer,1 C. Suter,1 Ch. Klaiber,2 H. Wehrli, 2 E. Frei,2 L. Kra henbuhl1

1 Department of Visceral and Transplantation Surgery, Inselspital University of Berne, CH-3010 Berne, Switzerland2 Swiss Association for Laparoscopic and Thoracoscopic Surgery (SALTS)

Received: 4 April 1997/Accepted: 9 July 1997

AbstractBackground:Spilled gallstones after laparoscopic cholecys-tectomy may cause abscess formation, but the exact extentof this problem remains unclear.Method: The data (collected by the Swiss Association ofLaparoscopic and Thoracoscopic Surgery) on 10,174 pa-tients undergoing laparoscopic cholecystectomy at 82 sur-gical institutions in Switzerland between January 1992 andApril 1995 were retrospectively analyzed with special in-terest in spilled gallstones and their complications.Results:In 581 cases (5.7%) spillage of gallstones occurred;34 of these cases were primarily converted to an open pro-cedure for stone retrieval. Of the remaining 547 cases onlyeight patients (0.08%) developed postoperatively abscessformation requiring reoperation.Conclusions:Spillage of gallstones after laparoscopic cho-lecystectomy is fairly common and occurs in about 6% ofpatients. However, abscess formation with subsequent sur-gical therapy remains a minor problem. Removal of spilledgallstones is therefore not recommended for all patients, butan attempt at removal should be performed whenever pos-sible.

Key words: Laparoscopy — Cholelithiasis — Spilled gall-stones — Complications after laparoscopic cholecystecto-my — Abdominal abscess

Laparoscopic cholecystectomy has rapidly become the stan-dard treatment for symptomatic cholelithiasis and acutecholecystitis in western countries [7, 12]. Today, laparo-scopic cholecystectomy has shown to be a safe and effectiveprocedure in experienced hands and carries therefore a lowmorbidity and mortality rate [2, 3, 9]. However, introduc-tion of laparoscopic cholecystectomy was associated withsome new complications, which have been rare with tradi-

tional open cholecystectomy. An increased incidence of ma-jor bile duct injuries, especially during the learning curve,has been reported by many authors [8, 10]. Iatrogenic bileduct injuries probably represent the most serious complica-tion of laparoscopic cholecystectomy and have thereforeattracted the most attention. Perforation of the gallbladderwith intraabdominal spillage of gallstones is a commonproblem after laparoscopic cholecystectomy although it isnot considered to be as serious. The reported rate of gall-bladder perforation after laparoscopic cholecystectomy var-ies from 10 to 32% [1, 4, 11, 14]. Mostly, inadvertent open-ing of the gallbladder occurs during the dissection from theliver bed. Furthermore, rupture of the gallbladder can eitheroccur by tearing the gallbladder with grasping forceps orduring the extraction through the abdominal wall. Withopen cholecystectomy intraperitoneal spillage of gallstonesis easily recognized, and the lost stones can be retrievedwithout problems. Thus, retained gallstones were uncom-mon, and only one patient has been reported with intraab-dominal abscess formation several years after open chole-cystectomy [5].

The exact morbidity and complication rate of spilledgallstones after laparoscopic cholecystectomy are not wellinvestigated. It is known that spilled gallstones may causeabscess formation [6]. But the incidence of complicationsdue to spilled gallstones seems to be low or even very low[11]. Thus, it remains unclear if stone spillage should beconsidered an indication for conversion to an open proce-dure for stone retrieval.

The aims of this retrospective study were to investigatethe frequency, the complications, and therapy of spilledgallstones after laparoscopic cholecystectomy.

Patients and methods

The Swiss Association for Laparoscopic and Thoracoscopic Surgery(SALTS) prospectively collects the data of patients undergoing cholecys-tectomy at 82 surgical institutions (universities, county and district hospi-tals, and surgeons in private practice) in Switzerland. More than 350 singleitems of data including personal records, ASA classification, indication forsurgery, preoperative investigations, intraoperative findings, operativeCorrespondence to:L. Krahenbuhl

Surg Endosc (1998) 12: 305–309

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complications, conversion rate, postoperative morbidity, reoperation rate,and mortality were recorded for every patient on a specially designedcomputerized worksheet [13].

The data of 10,174 laparoscopic cholecystectomies performed betweenJanuary 1992 and April 1995 were retrospectively analyzed with specialregard for intraabdominally spilled gallstones. All patients with lost gall-stones were identified. Their medical records and operative reports werecollected from the referring surgical institutions or the general practitioner;they were then asked to answer an additional questionnaire concerningfurther details and follow-up. If necessary, the institutions were visited ortelephoned by one of the investigators to collect data which were missing.The follow-up of all patients was guaranteed by contacting either thegeneral practitioner or the patient.

Data collected from chart review, telephone call, and questionnairewere then carefully reviewed, and the patients who had had complicationsfollowing spilled gallstones were identified. These few cases were thenfurther investigated using a previously created protocol with selected cri-teria from the literature.

Results are expressed as mean, standard deviation, and range values,respectively.

Results

Characteristics of patients

There were 3,103 male (30.5%) and 7,071 female patients(69.5%). The overall mean age at the time of operation was52.6 years (range 2–96 years).

Among the 10,174 patients, there were 581 patients(5.7%) with intraoperative gallstone spillage into the peri-toneal cavity. Their mean age was 55.6 years (range 19–92years); 547 of these 581 operations were finished laparo-scopically, whereas in 34 cases the operation was convertedto an open procedure during which all the spilled gallstoneswere removed.

Only eight patients (0.08%, five men and three women)with a mean age of 62.1 years (range 39–79 years), could beidentified as having had a serious postoperative complica-tion due to intraabdominally lost gallstones. The baselinedata are shown in Table 1.

Indications of laparoscopic cholecystectomy

Symptomatic cholecystolithiasis was the main indication forpatients undergoing laparoscopic cholecystectomy (62.5%),

followed by acute cholecystitis (10.3%) and some less fre-quent indications (15.2%, i.e., choledocholithiasis, biliarypancreatitis, polyps of the gallbladder). Patients undergoinglaparoscopic cholecystectomy for acute cholecystitis hada higher incidence of intraabdominal gallstone spillage.Therefore, in the group with conversion to an open proce-dure for stone retrieval, as well as in the group with seriouspostoperative complications, 23.5% and 37.5% of the pa-tients underwent laparoscopic cholecystectomy for acutecholecystitis, respectively (Table 1).

Operating time

The ‘‘French’’ procedure, with the surgeon’s position be-tween the patient’s legs, is the most common surgical tech-nique in Switzerland. As shown in Table 1, more than 80%of the laparoscopic cholecystectomies in the overall laparo-scopic group were performed within 120 min. However,spillage of gallstones markedly increased the operatingtime, and at least one-third of these operative procedureslasted more than 120 min. Of course, conversion to the openprocedure caused an even longer operating time. Neverthe-less, patients with serious postoperative complications dueto spilled gallstones did not have longer operating timesthan patients with ‘‘simple’’ spillage of gallstones.

Intraabdominally spilled gallstones: postoperativecomplications, postoperative reoperation, andintervention rate

As previously mentioned, there were 581 patients (5.7%)with intraabdominally spilled gallstones. Nearly all the pro-cedures were finished laparoscopically; only 34 patients(5.8%) had a conversion to an open procedure for stoneretrieval. Comparing these two patient groups, we found aconsiderably lower rate (5.9 vs 10.8%) of local postopera-tive complications in the group with conversion. In particu-lar, no complications due to common bile-duct stones, bileleakage, bleeding, or spilled gallstones occurred. However,the systemic complication rate, i.e., cardiac failure, pulmo-

Table 1. Characteristics of patients, indication for LC and operating time

CharacteristicOverallCE group

LC with spilledgallstones,no conversion

LC with spilledgallstonesand conversion

LC with spilledgallstonesand complications

No. of patients 10,174 547 34 8M:F (%) 3,103:7,071 249:298 15:19 5:3

(31:69) (46:54) (44:56) (62:38)Mean age, range 52.6 55.4 59.1 62.1

(years) (2–96) (19–92) (30–82) (39–79)Indication (%)

CCL 7,579 (74.5) 369 (67.5) 24 (70.6) 5 (62.5)AC 1,049 (10.3) 82 (15.0) 8 (23.5) 3 (37.5)Other 1,546 (15.2) 96 (17.5) 2 (5.9) 0 (0.0)

Operating time (%)<60 min 26.8 9.2 0 060–120 min 55.5 54.8 47.1 62.5>120 min 17.7 36.0 52.9 37.5

AC, acute cholecystitis; CE, cholecystectomy; CCL, cholecystolithiasis; LC, laparoscopic cholecystec-tomy; Other: common bile-duct stones, gallbladder polyps, biliary pancreatitis.

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nary complications, and thromboembolism, was higher(11.8 vs 7.7%) in the group with conversion.

The reoperation rate was 0% and 5.5% for the groupswith conversion and without conversion, respectively. Bileleakage, intraabdominal abscess formation, and bleedingwere the main reasons for reoperation. None of the 34 pa-tients whose operations were converted to an open proce-dure for stone retrieval developed any further problemsfrom spilled gallstones (Table 2).

Serious postoperative complications due to spilledgallstones requiring reoperation

Among the 10,174 patients undergoing laparoscopic chole-cystectomy we identified eight patients (0.08% for the over-all group or 1.4% of those with spilled gallstones, respec-tively) with serious postoperative complications followingintraabdominally spilled gallstones. There were five menand three women. Mean age at the time of operation was62.1 years (range 39–79 years). Five patients underwentlaparoscopic cholecystectomy for cholecystolithiasis, whilethe remaining three were operated on for acute cholecystitis.Six operations were elective procedures, whereas two wereperformed as emergencies. All the patients, bar one, devel-oped intraabdominal abscess formation requiring reopera-tion. Three of these seven patients not only developed anintraabdominal abscess but also fistulas and abscess forma-tion into the abdominal wall. In one patient who complainedpostoperatively of upper abdominal pain, gallstones had be-come sandwiched between the liver and the diaphragm in-traoperatively. Reoperation was always performed by openaccess. Four patients were reoperated in the early postop-erative course (2–21 days); the remaining four patients werereoperated on after 2.3, 4.5, 5.0, and 18.4 months. Gall-stones were found in seven patients. In four cases, bacterialgrowth was detected; in the remaining four cases, bacterialculture was either negative or not performed. Unfortunately,chemical analysis of the retrieved gallstones was only per-

formed in one case. Also, the number and the size of thegallstones were only poorly documented (Table 3).

Follow-up

Follow-up time was 16–56 months. None of the eight pa-tients with abscess formation who had required reoperationhad further complications. They all recovered fully and theirfurther postoperative course was uneventful. The same un-eventful postoperative course was found in the patient groupwith conversion to an open procedure.

Discussion

The purpose of our current study was to investigate theclinical relevance of spilled gallstones after laparoscopiccholecystectomy. To this end, the data of 10,174 laparo-scopic cholecystectomies performed at 82 surgical institu-tions in Switzerland were retrospectively analyzed.

Intraoperative spillage of gallstones occurred in 5.7% ofour cases. Since Fitzgibbons has suggested that spillage ofgallstones occurs in about two-thirds of gallbladder perfo-ration [4], the effective perforation and rupture rate of thegallbladder is probably even higher, although it did notoccur in our study. The perforation rate of the gallbladderaccording to the literature varies considerably, from 10 to32% [1, 4, 10, 11]. The exact number of lost gallstones wasnot recorded by SALTS and thus could not be evaluated.However, in the small group of patients with postoperativecomplications, more than one lost gallstone was found in theperitoneal cavity.

Symptomatic cholelithiasis was the most frequent indi-cation for laparoscopic cholecystectomy, followed by acutecholecystitis. Patients with acute cholecystitis had an in-creased rate of spilled gallstones as well as a higher com-plication rate. On the other hand, patients who underwent

Table 2. Intraabdominally spilled gallstones: complications, reoperation, and intervention rate

LC with spilled gallstonesno conversion(n 4 547)

LC with spilled gallstonesand conversion(n 4 34)

Postoperative complications (%)Local: 59 (10.8) 2 (5.9)

–CBD stones 8 0–Bile leakage 18 0–Intraabd. abscess formation 8 0–Intraabd. bleeding 7 0–Ileus 1 0–Trocar herniation 1 0–Trocar hematoma 10 0–Wound infection 6 2

Systemic: 42 (7.7) 4 (11.8)–Pulmonary embolism 1 2–Cardiopulmonary insuffic. 15 1–Sepsis 2 0–Urinary tract infection 5 0–Other 19 1

Reoperation rate (%) 5.5 0

CBD, common bile duct; LC, laparoscopic cholecystectomy.

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laparoscopic cholecystectomy for cholelithiasis had a lowerconversion rate and also a lower complication rate due tospilled gallstones.

Spillage of gallstones extended the operating time, butthere was no difference between the patient group with‘‘simple’’ spillage of gallstones and those with postopera-tive complications.

Although we found 581 patients (5.7%) with intraab-dominally lost gallstones, spillage of gallstones only led toconversion to an open procedure for stone retrieval in 34cases. Therefore, it can be suggested that either the majorityof the spilled stones were completely retrieved or they wereso utterly lost in the peritoneal cavity that the surgeonsdecided not to search for them. The exact reasons why thespilled gallstones led to conversion are unknown.

Different complication rates were found for local andsystemic complications. Local complications were mark-edly more frequent in the group with ‘‘simple’’ spillage ofgallstones compared to the group with conversion for stoneretrieval. In particular, no complications due to commonbile-duct stones, bile leakage bleeding, or spilled gallstonesoccurred. Additionally, there were no complications relatedto laparoscopic access such as trocar hematoma and hernia-tion. However, systemic complications were more frequentafter conversion to an open procedure. Since these patientswere older and their operating time was longer, they possi-bly had an increased risk of systemic complications.

Although intraabdominal spillage of gallstones was notan uncommon problem, complications following such spill-age were very rare, and only eight patients were identifiedamong these 10,174 cases. All these patients (five men andthree women) had a ‘‘simple’’ spillage of gallstones, and thelaparoscopic cholecystectomies were uneventful. The indi-cation for laparoscopic cholecystectomy was symptomaticcholelithiasis in five patients and cholecystitis in three pa-tients. Thus, this small patient group showed a threefoldincrease in the rate of acute cholecystitis compared to theoverall cholecystectomy group. Leakage of infected bileand gallstones are probably responsible for this increasedcomplication rate. Furthermore, the inflamed wall of thegallbladder is vulnerable and the local inflammatory reac-tion makes the dissection more difficult. Intraabdominal ab-scess formation, which is also the most frequent complica-

tion in the literature, occurred in seven patients [6]. Onepatient was reoperated on 2 days after the laparoscopic cho-lecystectomy and so in all likelihood had not yet developedabscess formation in this short postoperative period. But allof these eight patients were reoperated on with open access.Four patients were reoperated on early after laparoscopiccholecystectomy (within the first 3 postoperative weeks),among whom were all three cases with acute cholecystitis.The remaining four patients developed abscess formationand cutaneous fistula in the late postoperative course. Gall-stones of different size and number were found in sevencases. Chemical analysis was only performed in one case,which revealed bilirubin stones. In four cases, bacterialgrowth was detected with four different types of bacteria. Intwo cases, the bacterial cultures were sterile, and in theremaining two cases no bacterial culture was performed.

During the follow-up time, all patients who underwentreoperation due to septic complications or with conversionto an open procedure for stone retrieval developed furthercomplications, but no mortality occurred. Therefore, allthese additional operative procedures were successful.

The final question is whether spillage of gallstones is anindication for conversion to an open procedure for stoneretrieval. Although spillage of gallstones may lead to severepostoperative complications, the incidence and the mortalityare low, even very low. Thus, obligatory conversion to anopen procedure for stone retrieval is inappropriate. How-ever, an attempt should always be made to remove spilledgallstones and to irrigate the abdominal cavity.

In conclusion, spillage of gallstones during laparoscopiccholecystectomy is a common problem (5.7%), but seriouspostoperative complications are fortunately very rare(0.08%). Elderly patients with acute cholecystitis with in-fected bile and spilled stones may have an increased risk ofintraabdominal abscess formation. Therefore, perforationand rupture of the gallbladder should be prevented when-ever possible. In cases of spilled gallstones, the surgeonmust try to retrieve these lost gallstones and the abdominalcavity should be irrigated to dilute the infected bile andspilled gallstones. But there is no need for obligatory con-version to an open procedure for stone retrieval because theincidence and the mortality rate of serious complications areso low.

Table 3. Patients with serious postoperative complication due to intraabdominally spilled gallstones

Patient SexAge(years) ASA Ind.

Reop(days) Complication Bacterial culture

Gallstones

<5mm

5–10mm

>10mm

sizeunknown

no GSfound

1 M 39 1 CCL 150 Fistula of the umbilicus,intraabdominal abscess

Not performed +

2 M 53 1 AC 2 Irritation of the diaphragm Negative +3 M 62 2 AC 21 Intraabdominal abscess Enterococcus faecalis +4 M 75 2 AC 3 Intraabdominal abscess Negative +5 M 79 2 CCL 552 Intraabdominal abscess Streptococcus milleri +6 F 41 1 CCL 10 Abscess formation

intraabdominally andabdominal wall

Pseudomonas aeruginosa +

7 F 69 2 CCL 70 Fistula of the abdominalwall

Not performed +

8 F 79 3 CCL 132 Intraabdominal abscess Escherichia coli +

AC, acute cholecystitis; CCL, cholecystolithiasis; GS, gallstone; Ind., indication; Reop., reoperation (days after the first operation).

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References

1. Catarci M, Zaraca F, Scaccia M, Carboni M (1993) Lost intraperito-neal stones after laparoscopic cholecystectomy: harmless sequela orreason for reoperation? Surg Laparosc Endosc 3: 318–322

2. Cuschieri A, Dubois F, Mouiel J, Mouret P, Becker H, Buess G, TredeM, Troidl H (1991) The European experience with laparoscopic cho-lecystectomy. Am J Surg 161: 385–387

3. Deziel DJ, Millikan KW, Economou SG, Doolas A (1993) Complica-tions of laparoscopic cholecystectomy: a national survey of 4,292 hos-pitals and an analysis of 77,604 cases. Am J Surg 165: 9–14

4. Fitzgibbons RJ, Annibali R, Litke BS (1993) Gallbladder perforationand gallstone removal: open versus closed laparoscopy and pneumo-peritoneum. Am J Surg 165: 497–504

5. Jacob H, Rubin KP, Cohen MC, Kahn IJ, Kan P (1979) Gallstones ina retroperitoneal abscess: a late complication of perforation of thegallbladder. Dig Dis Sci 24: 964–966

6. Lauffer JM, Krahenbuhl L, Baer HU, Mettler M, Buchler MW (1997)Clinical manifestations of lost gallstones after laparoscopic cholecys-tectomy. A case report with review of the literature. Surg LaparoscEndosc 7: 103–112

7. NIH consensus conference statement on gallstones and laparoscopiccholecystectomy. (1993) Am J Surg 165: 390–398

8. Russell JC, Walsh SJ, Mattie AS, Lynch JT (1996) Bile duct injuries,1989–1993. A statewide experience. Arch Surg 131: 382–388

9. Schlumpf R, Klotz HP, Wehrli H, Herzog U (1993) LaparoskopischeCholezystektomie in der Schweiz: Kritischer Ru¨ckblick auf die ersten3,722 Fa¨lle. Chirurg 64: 307–313

10. Shea JA, Healey MJ, Berlin JA, Clarke JR, Malet PF, Staroscik RN,Schwartz JS (1996) Mortality and complications associated with lap-aroscopic cholecystectomy. Ann Surg 224: 609–620

11. Soper NJ, Dunnegan DL (1991) Does intraoperative gallbladder per-foration influence the early outcome of laparoscopic cholecystectomy?Laparosc Endosc 1: 156–161

12. Soper NJ, Stockmann PT, Dunnegan DL, Ashley SW (1992) Laparo-scopic cholecystectomy: the new gold standard. Arch Surg 127: 917–923

13. Wehrli H, Klaiber Ch, Frei E, Metzger A, Bu¨hler M (1995) The Swissexperience with laparoscopic cholecystectomy. In: Bu¨chler MW, FreiE, Klaiber Ch, Krahenbuhl L (eds) Five years of laparoscopic chole-cystectomy: a reappraisal. Progress in Surgery, vol 22. Karger, Basel,pp 46–55

14. Wetscher G, Schwab G, Fend F, Glaser K, Ladurner D, Bodner E(1994) Subcutaneous abscess due to gallstones lost during laparoscop-ic cholecystectomy. Endoscopy 26:324–325

Acknowledgments.Thanks are due to all the following surgeons and sur-gical institutions who contributed to this national study:

Public HospitalKantonsspital Aarau Kreisspital Muri, AargauSpital Aarberg Hopital de la Providence, NeuenburgBezirksspital Affoltern, Zu¨rich Bezirksspital NiederbippKantonsspital Baden Bezirksspital OberdiessbachKantonsspital Basel Kantonsspital OltenClaraspital Basel Hopital de Zone, PayerneKlinik f. Viszerale u. Kreisspital Pfa¨ffikonTransplantationschirurgie, Inselspital Bern Paracelsus-Spital RichterswilTiefenauspital Bern Spital RichterswilZieglerspital Bern Gemeindespital RiehenRegionalspital Biel Kreisspital Ru¨ti, Ruti, ZurichBezirksspital Thierstein, Breitenbach Kantonsspital Obwalden, SarnenOberwalliser Kreisspital, Brig-Glis Kantonsspital SchaffhausenKantonsspital Bruderholz, Basel-Land Spital Limmattal, Schlieren Zu¨richKreisspital Bulach Burgerspital SolothurnHopital La Chaux-de-Fonds Kantonsspital St. GallenKantonsspital Chur Bezirksspital SumiswaldSpital Davos, Davos-Platz Regionalspital ThunThurgauisches Kantonsspital, Frauenfeld Spital ThusisKantonsspital Glarus Spital UsterSpital Grenchen Kantonales Spital, UznachBezirksspital Grossho¨chstetten Ospedale Italiano di Lugano, ViganelloKantonales Spital, Heiden Kantonales Spital, WalenstadtKantonales Spital, Herisau Spital WattwilRegionalspital Horgen Kreisspital WetzikonBezirksspital Fraubrunnen, Jegenstorf Spital Wil, St. GallenRegionalspital Surselva, Ilanz Kantonsspital WinterthurRegionalspital Langenthal Bezirksspital ZofingenCHUV, Lausanne Spital Neumu¨nster, ZollikerbergOspedale Civico, Lugano Stadtspital Triemli, Zu¨richKreisspital Mannedorf Unispital ZurichOspedale Mendrisio Stadtspital Waid, Zu¨richSpital Menziken Kantonsspital ZugBezirksspital Meyriez, Murten Bezirksspital ZweisimmenKantonsspital Mu¨nsterlingen

Surgeons in pivate practicePD Dr. J. Baltensweiler, Zu¨rich Dr. Ch. U. Krayenbu¨hl, ZurichDr. D. Baumgartner, Luzem Dr. K. H. Leemann, ZugDr. U. Brand, Genf Dr. A. Osterwalder, LuganoDr. J. Burri, Freiburg Dr. P. Petignat, BielDr. J. Dbaly, Bern Dr. Th. P. Ricklin, ZurichDr. C. Ghielmetti, Thun Dr. R. A. Schori, BernDr. M. Herrmann, Onex

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History

J. B. Murphy, M.D.

Of buttons and blows

L. Morgenstern

Division of General Surgery, Department of Surgery, Cedars-Sinai Research Institute, Cedars-Sinai Medical Center, and Department of Surgery,UCLA School of Medicine, 444 South San Vicente Boulevard, Los Angeles, CA 90048-1869, USA

Received: 19 September 1995/Accepted: 27 September 1995

John Benjamin Murphy (1857–1916) (Fig. 1), fabled sur-geon ‘‘extraordinary’’ and ‘‘stormy petrel of American sur-gery’’ [1] at the turn of the century, deserves a note ofrecognition in the annals of endoscopy and biliary surgery.

In 1912, in the Surgical Clinics of North America [2],Murphy described the insertion of a cystoscope into a chole-cystostomy tract for removal of a residual stone. This wasaccomplished successfully by passing a hook through thecystoscope. The maneuver was an early forerunner of asimilar endoscopic maneuver in use today for residual bil-iary calculi.

Cholecystostomy, however, was J.B. Murphy’s secondchoice for the operative treatment of cholecystic disease.

His preference was for cholecystoenterostomy, over eithercholecystostomy or cholecystectomy.

To facilitate the joining of the gallbladder to the intes-tine, Murphy devised a hollow-cored spherical device di-visible into two hemispheres, over which the purse-stringedsegments to be anastomosed could be affixed. The twohalves of the brass ‘‘button,’’ when then joined and lockedtogether, achieved a rapid apposition of the two segments.The metal sphere was then ‘‘passed’’ within weeks afterinsertion, leaving the anastomosis intact. He called this de-vice ‘‘the Anastomosis Button.’’ It is better known as ‘‘theMurphy Button’’ (Fig. 2).

Six days after using his newly devised ‘‘Anastomosis

Fig. 1. John Benjamin Murphy (1857–1916).

Fig. 2. The ‘‘Murphy button’’ as originally described by J. B. Murphy.

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Button’’ [3] for the first time on a dog, he performed acholecystoenterostomy on a 35-year-old, severely jaundicedwoman, joining the gallbladder with the jejeunum by meansof the button. The gallstones were not removed. ‘‘Timefrom opening of the peritoneum until the closing of same,eleven minutes.’’ In Murphy’s hands, use of the button re-duced operating time for this anastomosis tenfold. Aftervisiting Murphy’s clinic, the Mayo brothers, William andCharles, adopted the ‘‘Murphy Button’’ for use in the MayoClinic, where the button was in common usage until 1935.

But neither the ‘‘Murphy Button’’ nor cholecystoen-terostomy for gallstone disease were durable contributionsof this remarkable surgeon. He is probably best rememberedeponymically for his ‘‘Murphy’s sign’’ in acute cholecys-titis (Figs. 3, 4).

As originally described by Murphy, Murphy’s sign en-tailed percussion of the right midsubcostal region with thebent middle finger of the left hand, using the right hand tostrike the dorsum of the left hand with hammer-like blows[4]. As commonly elicited today by legions of medical stu-dents, interns, residents, and their elders, it is a ‘‘fist’’ per-

cussion, which Murphy described for demonstrating CVAtenderness in patients with ureteral obstruction rather thanfor acute cholecystitis.

Murphy’s niche in the history of American surgery issecure. A small part of that niche was carved by his exploitsin the biliary tract, by endoscope, anastomotic button, andthe ubiquitously used but now transmuted ‘‘Murphy’ssign,’’ the diagnostic ‘‘blow’’ signaling acute cholecystitis.

References

1. Davis L (1938) Surgeon extraordinary; the life of J. B. Murphy. Fore-word by A. J. Cronin. George G. Harrap London & Co.

2. Murphy JB (1912) Surgical clinics of John B. Murphy, M.D. at MercyHospital, Chicago. Cholelithiasis 1: 417

3. Murphy JB (1892) Cholecysto-intestinal, gastrointestinal, enter-intestinal anastomosis, and approximation without sutures. Med Rec42: 665

4. Schmitz RL, Oh TT (eds) (1993) The remarkable surgical practice ofJohn Benjamin Murphy. University of Illinois Press, Urbana-Cham-paign, p 29

Fig. 3. The original Murphy maneuver for eliciting‘‘Murphy’s Sign.’’ The middle finger of the left hand isused as the ‘‘anvil.’’

Fig. 4. The original Murphy maneuver for eliciting‘‘Murphy’s Sign.’’ The ‘‘hammer-stroke’’ is deliveredsharply by the edge of the right hand over the gallbladderarea.

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Laparoscopic endobiliary stenting as an adjunct to common bileduct exploration

K. S. Gersin, R. D. Fanelli

Department of Surgery, Berkshire Medical Center, 725 North Street, Pittsfield, MA 01201, USA

Received: 28 March 1992/Accepted: 3 August 1997

AbstractBackground:The management of common bile duct stones(CBDS) in the era of operative laparoscopy is evolving.Several minimally invasive techniques to remove CBDShave been described, including preoperative endoscopic ret-rograde cholangiopancreatography (ERCP), postoperativeERCP, lithotripsy, laparoscopic transcystic common bileduct exploration, and laparoscopic choledochotomy withcommon bile duct exploration (CBDE). Because of the risksand limitations of these procedures, we utilize laparoscopi-cally placed endobiliary stents as an adjunct to CBDE.Methods:Sixteen patients underwent laparoscopic commonbile duct exploration (LCBDE) by either choledochotomyor the transcystic technique with placement of endobiliarystents. These patients were identified during laparoscopiccholecystectomy as having occult choledocholithiasis, usingroutine dynamic intraoperative cholangiography.Results:CBDS were successfully removed in all patients asdemonstrated by completion cholangiography and intra-operative choledochoscopy. Eighty percent of patients weredischarged the following day; the first three patients in thisseries were observed for 48 h prior to discharge. No patientrequired T-tube placement and closed suction drains wereremoved the morning after surgery. Stents were removedendoscopically at 1 month. Six- to 30-month follow-updemonstrates no complications to date.Conclusions:Laparoscopic endobiliary stenting reduces op-erative morbidity, eliminates the complications of T-tubes,and allows patients to return to unrestricted activity quickly.We recommend laparoscopically placed endobiliary stentsin patients undergoing LCBDE.

Key words: Laparoscopic endobiliary stenting — ERCP —Laparoscopic common bile duct exploration — Laparoscop-ic cholecystectomy — Common bile duct stones

The management of common bile duct stones (CBDS) in theera of laparoscopic cholecystectomy is evolving. Severaltechniques for treatment of CBDS have become popular,including preoperative endoscopic retrograde cholangiopan-creatography (ERCP), postoperative ERCP, endobiliarylithotripsy, laparoscopic common bile duct exploration(LCBDE), and conversion to laparotomy with bile duct ex-ploration [1, 2, 7, 14, 19–21, 23]. Several novel tech-niques such as intraoperative ERCP and antegrade endo-scopically guided sphincterotomy have been advocatedby some but remain largely unavailable to the majority ofsurgeons [8, 9]. LCBDE has been performed by the trans-cystic route as well as by choledochotomy with stone ex-traction.

Although each of the above techniques addresses theproblem of CBDS, none is ideal. Preoperative ERCP isappropriate for some patients, but those with occult CBDSwill not benefit from selective application of this technique.The routine use of postoperative ERCP may require thatsome patients undergo a second operative procedure forstone extraction if endoscopic clearance is unsuccessful.Contact lithotripsy requires expensive specialty equipmentwhich is unavailable in many hospitals. Thus, the majorityof laparoscopic surgeons faced with the problem of CBDSmust rely on LCBDE or conversion to laparotomy for openCBDE with placement of drains and T-tubes.

Procedures which rely on the placement of T-tubes re-quire that patients remain hospitalized for several days post-operatively. Even after discharge, indwelling T-tubes areuncomfortable, require continuous management, and sig-nificantly limit patient activity because of the risk of dis-lodgment. Conversion to open surgery increases hospital

Presented at the annual meeting of the Society of American Gastrointes-tinal Endoscopic Surgeons (SAGES), San Diego, California, USA, 20–21March 1997

Correspondence to:R. D. Fanelli, Surgical Specialists of Western NewEngland, P.C., 510 North Street, Pittsfield, MA 01201, USA

Surg Endosc (1998) 12: 301–304

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lengths of stay, prolongs convalescence, and is associatedwith greater morbidity than laparoscopic surgery [6, 12, 16,22].

We describe a method of LCBDE with placement of anendobiliary stent which obviates the need for T-tube place-ment, eliminates the morbidity of open CBDE, and allowspatients to return to activity as quickly as those undergoinglaparoscopic cholecystectomy without CBDE [17]. The lap-aroscopic placement of endobiliary stents also guaranteesaccess to the common bile duct, ensuring success in cases

where postoperative ERCP may still be necessary, such asmultiple stones or stones high in the proximal biliary tree.

Materials and methods

Sixteen patients undergoing laparoscopic cholecystectomy for symptom-atic cholelithiasis during a 3-year period were found on routine intraop-erative dynamic cholangiography to have CBDS (Fig. 1). Each patientunderwent laparoscopic transcystic CBDE or laparoscopic choledo-chotomy with CBDE. Under dynamic, fluoroscopic imaging, soft wire

Fig. 1. Choledocholithiasis discovered during routine intraoperative dynamic cholangiography. Note the stone in the proximal ductal system.

Fig. 2. After creating a choledochotomy a soft wire basket is used to extract the CBDS. Baskets are also used via the transcystic route when feasible.

Fig. 3. An alternative to basket retrieval is forced irrigation of the distal CBD after placement of a biliary balloon catheter. Small stones and debris maybe flushed from the duct.

Fig. 4. Once clearance of all CBDS is confirmed, a 450 cm by 0.0359 Zebra guidewire is introduced through the cholangiogram catheter and placed acrossthe ampulla where it gently curls within the duodenum.

Fig. 5. A 5-cm-long 7-French Microvasive Solopass Percuflex endobiliary stent is advanced over the guidewire until its distal tip lies within the duodenum.Once the stent is positioned and deployed, the delivery mechanism and guidewire are removed.

Fig. 6. After successful placement of the stent, the choledochotomy is closed with sutures and the cystic duct is divided. Laparoscopic cholecystectomyis then completed, and a closed suction drain is placed.

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baskets and balloon irrigation catheters were used to clear the CBDS (Figs.2 and 3). Completion cholangiography was routinely performed to ensurethe adequacy of stone clearance after LCBDE. Intraoperative choledochos-copy was performed in all cases where choledochotomy was utilized and incases of transcystic LCBDE where cystic duct size was sufficient forintroduction of the choledochoscope (Karl Storz 40× flexible fiberopticureteroscope, model #11274AA).

Once successful CBDS clearance was confirmed, a 0.035-inch-wide by450-cm-long Zebra guidewire (Microvasive catalog #5168) was placedacross the ampulla into the duodenum either through the cystic duct or thecholedochotomy (Fig. 4). Under digital fluoroscopic guidance, a 7-French,5-cm SoloPass Percuflex endobiliary stent (Microvasive catalog #3405)was advanced over the guidewire until the distal tip entered the duodenum(Fig. 5). The injection of contrast through the stent delivery mechanismallows excellent visualization of the stent’s location, ensuring appropriatepositioning across the ampulla.

After successful deployment of the stent, cystic duct stump ligation wasaccomplished (Fig. 6) using either endoclips (Ethicon endoscopic rotatingmultiple clip applier ER320) or 2-0 Vicryl ligatures (Ethicon catalog#J286G). When choledochotomy had been utilized, closure was accom-plished with interrupted 4-0 Vicryl sutures (Ethicon catalog #J214). Aclosed suction drain was placed after completion of the laparoscopic cho-lecystectomy and patients were admitted for overnight observation.

Results

All 16 patients had successful laparoscopic clearance ofCBDS as demonstrated by completion cholangiography.Choledochoscopy was an effective adjunct when fluoro-scopically guided soft wire basket stone extraction was un-successful or when multiple stones were present. The firstthree patients in this series were observed for 48 h prior todischarge; all subsequent patients have been discharged themorning after surgery. None of these patients required T-tube placement and all patients with occult CBDS duringthe study period were managed by this method. Closed suc-tion drains had been placed routinely and were removedprior to discharge after inspection revealed no evidence ofbile leak. Stents were removed endoscopically at 1 month,and retrograde cholangiograms obtained during ERCP dem-onstrated no retained stones, bile duct strictures, or bileleaks. Two patients did not undergo postoperative ERCPbecause of spontaneous passage of their endobiliary stentsnoted on plain radiographs taken for evaluation of nonbili-ary pathology. Six- to 30-month follow-up demonstrates nocomplications to date.

Discussion

Laparoscopic endobiliary stent placement eliminates reli-ance on postoperative T-tubes. Patient comfort is improvedand there are no complications related to indwelling T-tubesincluding biliary leaks, common bile duct obstruction, duo-denal erosions, and retained portions of T-tubes [3, 5, 15,18]. Our results demonstrate that transductal laparoscopicplacement of endobiliary stents following LCBDE allowsearly return to activity, provides decompression of the com-mon bile duct, and guarantees successful cannulation of theCBD during postoperative ERCP when necessary. There areno complications from stent placement to date and all stentswere successfully removed postoperatively.

Surgeons unable to clear CBDS entirely during LCBDEbecause of multiple proximal stones or low insertion of thecystic duct may employ this technique since it eliminates

the risk that patients with retained CBDS will require asecond surgical procedure. Although we were able to clearCBDS in all cases, others have reported a CBDS clearancerate ranging from 81 to 100% after LCBDE [4, 9, 10]. Incases of incomplete stone removal, the transampullary en-dobiliary stent will provide effective biliary decompression,eliminating concern for postoperative gallstone pancreatitis,cholangitis, and obstructive jaundice. Since the use of en-dobiliary stents has been shown to be effective in the treat-ment of postoperative bile leaks, their use in protecting theprimary closure of the choledochotomy described hereinlimits the risk of bile leak [13].

Opponents may argue that a postoperative ERCP re-quired for stent removal may not be cost effective. How-ever, since completion cholangiography and choledochos-copy are highly effective in limiting the incidence of re-tained CBDS, with a 0% retained stone rate in this series,postoperative ERCP will not be necessary in many cases inwhich there was complete removal of CBDS. Stent removalmay be accomplished easily with esophagogastroduodenos-copy to avoid the risks and expense of ERCP. Additionalhospital costs are reduced with the realization that with theexception of the first three patients in our series, all patientswere discharged the morning following surgery. These re-sults compare favorably with a recent review by Ferzli inwhich the lengths of stay following LCBDE ranged from1.7 to 12.0 days [11].

In conclusion, the discovery of occult CBDS demands arational treatment approach that doesn’t increase morbidity,hospital expense, or negate the beneficial effects of laparo-scopic cholecystectomy. Many laparoscopic surgeons havemastered LCBDE, but their patients must still endure thelimitations of indwelling T-tubes. The above technique al-lows CBDS to be removed expeditiously without the prob-lems of T-tubes and preserves the benefits of laparoscopiccholecystectomy—namely, quick recovery and early returnto full activity. Our experience demonstrates this to be a safeand effective procedure.

Acknowledgment.The authors acknowledge medical illustrator RobinBrickman from Williamstown, Massachusetts, USA.

References

1. Abu-Khalaf A (1995) Endoscopic removal of retained common bileduct stones in patients with T tube in situ. Surg Laparosc Endosc 5:17–20

2. Arregui ME, Davis CJ, Arkush AM, Nagan RF (1992) Laparoscopiccholecystectomy combined with endoscopic sphincterotomy and stoneextraction or laparoscopic choledochoscopy and electrohydrauliclithotripsy for management of cholelithiasis with choledocholithiasis.Surg Endosc 6: 10–15

3. Benakis P, Nicolakis D, Triantafillidis JK (1994) Successful endo-scopic removal of part of a T-tube from the common bile duct. SurgEndosc 8: 1168–1174

4. Berci G, Morganstern L (1994) Laparoscopic management of commonbile duct stones. A multi-institutional SAGES study. Surg Endosc 8:1168–1174

5. Bernstein DE, Goldberg RI, Unger SW (1994) Common bile ductobstruction following T-tube placement at laparoscopic cholecystec-tomy. Gastrointest Endosc 40: 362–365

6. Cagir B, Rangraj M, Maffuci L, Ostrander LE, Herz BL (1994) Aretrospective analysis of laparoscopic and open cholecystectomies. JLaparendosc Surg 4: 89–100

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7. Carroll B, Chandra M, Papaioannou T, Daykhovsky L, Grundfest W,Phillips E (1993) Biliary lithotripsy as an adjunct to laparoscopiccommon bile duct stone extraction. Surg Endosc 7: 356–359

8. Curet MJ, Pitcher DE, Martin DE, Zucker KA (1995) Laparoscopicantegrade sphincterotomy. A new technique for the management ofcomplex choledocholithiasis. Ann Surg 221: 149–155

9. DePaula AL, Hashiba K, Bafutto M (1994) Laparoscopic managementof choledocholithiasis. Surg Endosc 8: 1399–1403

10. Ferzli GS, Massaad A, Ozuner G, Worth MH (1991) Laparoscopicexploration of the common bile duct. Surg Gynecol Obstet 4: 419–421

11. Ferzli GS, Hurwitz JB, Massaad AA, Piperno B (1996) Laparoscopiccommon bile duct exploration: a review. J Laparendosc Surg 6: 413–419

12. Gadacz TR (1993) U.S. experience with laparoscopic cholecystecto-my. Am J Surg 165: 450–454

13. Jenkins MA, Ponsky JL, Lehman GA, Fanelli RD, Bianchi T (1994)Treatment of bile leaks from the cystohepatic ducts after laparoscopiccholecystectomy. Surg Endosc 8: 193–196

14. Jones DB, Soper NJ (1996) The current management of common bileduct stones. Adv Surg 29: 227–233

15. Kacker LK, Mittal BR, Sikora SS, Ali W, Kapoor VK, Sacena R, DasBK, Kaushik SP (1995) Bile leak after T-tube removal—a scinti-graphic study. Hepatogastroenterology 42: 975–978

16. Kelley JE, Burrus RG, Burns RP, Graham LD, Chandler KE (1993)Safety, efficacy, cost, and morbidity of laparoscopic versus open cho-lecystectomy: a prospective analysis of 228 consecutive patients. AmSurg 59: 23–27

17. Lange V, Rau HG, Schardey HM, Meyer G (1993) Laparoscopic stent-ing for protection of common bile duct sutures. Surg Laparosc Endosc3: 466–469

18. Mosimann F, Schneider R, Mir A, Gillet M (1994) Erosion of theduodenum by a biliary T-tube: an unusual complication of liver trans-plantation. Transplant Proc 26: 3550–3551

19. Petelin JB (1993) Laparoscopic approach to common duct pathology.Am J Surg 165: 487–491

20. Stoker ME (1995) Common bile duct exploration in the era of lapa-roscopic surgery. Arch Surg 130: 265–268

21. Swanstrom LL, Marcus DR, Kenyon T (1996) Laparoscopic treatmentof known choledocholithiasis. Surg Endosc 10: 526–528

22. Unger SW, Rosenbaum G, Unger HM, Edelman DS (1993) A com-parison of laparoscopic and open treatment of acute cholecystitis. SurgEndosc 7: 377–379

23. Waters GS, Crist DW, Davoudi M, Gadacz TR (1996) Management ofcholedocholithiasis encountered during laparoscopic cholecystectomy.Am Surg 62: 256–258

Discussion

Dr. Schirmer: Thank you very much. I appreciate yourstudy. It was very nice. But I do have one concern, and thatis what you’re basically saying by your argument againstthe T-tube is that it prolongs recovery and it’s, therefore,more costly. However, have you compared that, the differ-ence in the hospitalization, with having to have a T-tubeversus the cost to go back and pull that stent out, becausethat’s another endoscopy, and that’s a fairly costly proce-dure as well.

Dr. Gersin: Right. We feel that the cost was offset by thefact that our patients were discharged within 24 hours,whereas in most of the literature the patients who did re-quire T-tubes and common bile duct explorations were inthe hospital for a period of time much longer than 24 hours.Second of all, the patients do require a repeat endoscopy,

but often this is just performed with a gastroscope, just tosnare the stent and remove it, so we do feel it to be costeffective.

Dr. Petelin:Congratulations, again, on a nice paper. I wouldecho the comments of the previous questioner, and I wouldsuggest that you’re not preserving all the benefits of lapa-roscopic cholecystectomy by leaving the stent. If it’s a dis-solvable stent or one that will pass on its own that probablyis the case, but the need to perform a second procedure doesincrease the risk. We have used primary closure in a numberof our patients without an indwelling stent, and it hasworked, so I guess I would ask you to consider the subse-quent procedure and bring us back some details on howmuch that does cost.

Dr. Gersin: Thank you, Dr. Petelin. Again, we did stent allof our patients, even if we explored them transcystically. Infact, it may prove to be unnecessary. However, due to ourconcerns of distal spasm and edema, we felt that it was safejust to provide a stent in those patients. I should also addthat the stent is an excellent adjunct if you’re unable tocompletely clear those stones, because it does guaranteesuccessful cannulation if postoperative ERCP is necessary.

Dr. Minasi: If you are taking your patients back and en-doscoping them at one month, and not restudying them, thenyou’re accepting a 1–3% chance of missing retained stonesthat you didn’t see at the time of your initial clearance. Doyou have any comment on that?

Dr. Gersin: We haven’t had any problems in the 30-monthfollow-up to date on retained stones, so that if, in fact, thereare retained stones, it would be, again, a very low percent-age, and no patients have had any complications from that.We do perform routine intraoperative choledochoscopy andcholangiography to try to minimize the incidence of therebeing retained stones.

Dr. Cosgrove:I enjoyed your presentation. My colleague,Marie Chen, has looked at the role of intraoperative ERCPfor the common duct stones. We have about 20 cases. Shehas reported this in abstract form. They have been success-ful removing the stones in all but two cases. Can you com-ment on what you feel the role of intraop ERCP is doing tolaparoscopic cholecystectomy?

Dr. Gersin: Yes, I think that’s a technique that certainly,currently is evolving. I think it’s a good technique. We havetried it on several of our patients. With the first two patientsthere was difficulty, due to positioning. We are more used tohaving our patients in the left lateral position, and the pa-tients who have it intraoperatively are obviously supine. I dothink it’s good; however, you must keep in mind that thereare several surgical colleagues who at this time are unable toperform ERCP, so if you’re a surgeon who can performintraoperative ERCP I think it’s an excellent idea.

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Biliary stenting is more effective than sphincterotomy in the resolutionof biliary leaks

J. M. Marks, 1,3 J. L. Ponsky,2 R. B. Shillingstad,1 J. Singh3

1 Department of Surgery, Case Western Reserve University School of Medicine, 11100 Euclid Avenue, Cleveland, OH 44106, USA2 Department of Endoscopic Surgery, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA3 Mount Sinai Medical Center, One Mount Sinai Drive, Cleveland, OH 44106, USA

Received: 19 March 1997/Accepted: 14 July 1997

AbstractBackground:Biliary fistulae may occur following surgicalinjury, abdominal trauma, or inadequate closure of a cysticduct stump. These leaks are most often managed by drain-age of the associate biloma and either endoscopic sphinc-terotomy or placement of a biliary endoprosthesis to de-crease the pressure gradient between the bile duct and theduodenum created by the muscular contraction of the am-pullary sphincter. In a previous study, we demonstrated astatistically significant reduction in ductal pressures follow-ing stent placement as compared to sphincterotomy. Thegoal of this present study was to determine if reduction inductal pressures correlates clinically with the resolution ofbiliary leaks in an animal model.Methods: Fourteen mongrel dogs underwent laparotomy,cholecystectomy without closure of the cystic stump, and alateral duodenotomy to identify the major papilla. The dogswere then randomized into three groups. Group I (n4 5)was a control group undergoing closure of the duodenotomyonly. Group II (n4 4) underwent sphincterotomy. GroupIII (n 4 5) underwent placement of a 7 Fr × 5 cmbiliaryendoprosthesis prior to duodenotomy closure. A drain wasplaced adjacent to the cystic duct stump in all groups. Drainoutput was recorded daily. The biliary leak was consideredresolved when the output was <10 cc/day. Regardless ofsuspected fistula closure, the drains were not removed until2 weeks postprocedure. Necropsy was performed to identifyundrained intraperitoneal bile. Statistical analysis was per-formed using Student’s pairedt test.Results:All dogs had bile leaks identified on postoperativeday 1. The number of days required for resolution of bileleak in group I (mean ± SEM) was 7.60 ± 0.87 days, ascompared to 6.75 ± 0.80 days for group II and 2.60 ± 0.24days for group III. There was no significant difference in theduration of bile leak between groups I and II (p 4 0.445).

Group III, however, had a significant reduction in the du-ration of biliary fistulae as compared to both groups I and II(p < 0.005). At autopsy, persistent bilomas were identifiedin 80% of group I, 25% of group II, and 0% of group III.None of the dogs showed evidence of dehisence of theduodenotomy closure site as a source of bile leak.Conclusions:Biliary stenting significantly reduces the timeto resolution of cystic duct leaks as compared to sphincter-otomy in a canine model. The results obtained in this studysupport the use of biliary endoprostheses in the managementof biliary leaks and fistulae.

Key words: Biliary fistulae — Endoscopic stent placement— Endoscopic sphincterotomy

Biliary fistulae may occur following surgical injury, pen-etrating or blunt abdominal trauma, or secondary to inad-equate closure of a cystic duct stump or accessory duct [12,21]. The majority of biliary tract leaks occur from the ex-trahepatic biliary tree. The management of these leaks in-cludes drainage of the intraperitoneal bile collection anddecompression of the bile duct. This requires the integrateduse of multiple modalities, including computed tomogra-phy, scintigraphy scanning, and endoscopic retrograde chol-angiography [3, 20, 25]. The preferred endoscopic treat-ment, however, has yet to be determined. Endoscopicsphincterotomy by electrosurgical division of the sphincterof Oddi is thought by some to provide adequate drainage ofthe common bile duct [13]. Others, however have proposedthe placement of biliary endoprostheses or nasobiliarytubes. The goal of both treatments is to decrease the pres-sure gradient between the bile duct and the duodenum cre-ated by the muscular contraction of the ampullary sphincter.Previous work by our lab showed that biliary endoprosthesisplacement led to a significant reduction in bile duct pres-sures, as compared to sphincterotomy. The goal of the pres-ent study was to determine if this reduction in ductal pres-sures correlates clinically with the resolution of biliary fis-tulae.

Presented at the annual meeting of the Society of American Gastrointes-tinal Endoscopic Surgeons (SAGES), San Diego, California, USA, 19–22March 1997Correspondence to:J. M. Marks

Surg Endosc (1998) 12: 327–330

© Springer-Verlag New York Inc. 1998

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Materials and methods

Fourteen mongrel dogs (mean weight, 20 kg) were fasted for 12 h preop-eratively. After being anesthetized with intravenous thiopental (10–20 mg/kg), acepromazine (2.5 mg), and atropine (0.08 mg/kg), they were endo-tracheally intubated with maintenance on a Harvard Pump respirator. Ad-ditional doses of thiopental were given as necessary to maintain adequateanesthesia. Following midline laparotomy, the gallbladder in all animalswas removed without closure of the cystic duct stump. A lateral duode-notomy was then created 6 cm distal to the pylorus and the major papillaidentified. The dogs were then randomized into three groups—a controlgroup (group I), a sphincterotomy group (group II), and a biliary stentgroup (group III). Randomization was performed by the selection of asealed envelope with a 39 × 59 card detailing the specific group. Group I,the control dogs, underwent a sham procedure with immediate closure ofthe duodenotomy. In group II, sphincterotomies were performed followingthe duodenotomy with a standard endoscopic 5-Fr 20-mm double-channelpapillotome (Wilson-Cook Medical Inc., Winston-Salem, NC, USA). A10-mm sphincterotomy was made using blended cutting current deliveredfrom a standard electrocautery generator (Valley Lab, Boulder, CO, USA).The dogs of group III, which was randomized to receive a biliary stent,underwent cannulation of the major papilla with a 0.035 in guide wire(Wilson-Cook Medical Inc.) and placement of a 7-Fr × 5-cm Cotton-Leungbiliary endoprosthesis (Wilson-Cook Medical Inc.).

The duodenotomy was closed in all cases with interrupted 3-0 silksutures. A closed drain system (Baxter Healthcare Corp., Deerfield, IL,USA) was placed adjacent to the cystic duct stump and tunneled subcuta-neously to exit posteriorly between the scapulae. Protective wraps wereplaced around the dog’s abdomen to prevent the dog from removing thedrains.

All dogs received clear liquids the night following surgery and wereadvanced to a regular diet the next day. Drain output was recorded daily.The biliary fistula was considered resolved when the output dropped to <10cc per day, but the drains were not removed until 2 weeks after surgery,when the dogs were euthanized with a lethal dose of pentobarbitol. Anecropsy was performed to identify undrained intraperitoneal bile or apersistent biloma.

All protocols were approved by the Animal Research Committee priorto this study. Statistical analysis was performed using Student’s pairedttest. Statistical significance was assigned top < 0.05. Results are expressedas mean ± SEM.

Results

In this study, 14 dogs were randomized to group I (n4 5),group II (n4 4), or group III (n4 5). All dogs had biliaryleaks identified on the 1st postoperative day. The number ofdays required for resolution of the biliary leak in group Iwas 7.60 ± 0.87 days, as compared to 6.75 ± 0.80 days forgroup II and 2.60 ± 0.24 days for group III (Fig. 1). Therewas no significant difference in the duration of biliary leaksbetween group I and group II (p 4 0.445). The group thatunderwent biliary stent placement, however, had a signifi-cant reduction in the duration of biliary leak as compared toboth the control and sphincterotomy groups (p < 0.005). Atautopsy, persistent bilomas were identified in 80% of groupI, 25% of group II, and 0% of group III. None of the animalshad duodenotomy dehisences identified as a source for bileleakage at autopsy.

Discussion

We designed this study to compare in a prospective ran-domized fashion the two endoscopic techniques currentlyavailable for the treatment of bile duct leaks. In previousanimal experiments, we found that biliary stent placementwas superior to endoscopic sphincterotomy in overcomingthe outflow resistance of the ampullary sphincter. There-

fore, we set out to determine the clinical significance of thisreduction in biliary pressures and ascertain if it correlatedwith the actual resolution of bile duct leaks.

The number of days required for resolution of bile leaksin the control dogs (group I) was 7.60 ± 0.87 days; it was6.75 ± 0.80 days in the dogs undergoing sphincterotomy(group II) and 2.60 ± 0.24 days in the biliary stent group(group III). There was no significant difference between thecontrol and sphincterotomy groups in the duration of thebile leaks (p 4 0.445). The biliary stent group, however,had a significant reduction in the duration of bile leaks ascompared to both the control and sphincterotomy groups (p< 0.005). At autopsy, no bilomas were identified in any ofthe dogs who had undergone biliary stent placement,whereas four of the five control dogs and one of the foursphincterotomy dogs did have persistent intraperitoneal bileat autopsy.

The incidence of common bile duct injuries followingopen cholecystectomy has been reported to be 0.07–0.1%[1, 16]. In contrast, the incidence of common bile ductinjuries following laparoscopic cholecystectomy appears tobe at least twice that of open cholecystectomy; recent re-ports have estimated the incidence to be 0.2–0.3% [17, 31,32, 38]. The rate of bile duct injury varies according to theexperience of each institution performing laparoscopic cho-lecystectomy. In one series, the incidence of bile duct injuryin institutions having performed <100 cases was 0.65%, ascompared to 0.42% in those that had performed >100 [11].Bile leaks were identified in 0.29% of patients in this seriesand represented the most common postoperative complica-tion. In most series, cystic duct leaks comprise∼20% of allbiliary tract injuries following laparoscopic cholecystecto-my [36].

The management of biliary fistulae has evolved with theadvancement of endoscopic techniques. In a review of 77cases of endoscopic management of postoperative biliaryleaks, Binmoeller et al. found the treatment to be successfulin 95% of cases [4]. This led to resolution of the biliaryleaks in 82% of the patients. The practice of intraperitonealbile drainage in combination with biliary duct decompres-sion is the standard therapeutic regimen. Percutaneousdrains have been placed under sonographic or CT guidance,and decompression of the biliary tree has been performed

Fig. 1. Daily outputs from the drains were reported for the control (solidtriangles), sphincterotomy (open circles), and the biliary stent groups (solidsquares).

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utilizing endoscopic sphincterotomy and/or biliary stentplacement. Whether sphincterotomy or stent placement re-sults in shorter time to closure of biliary leaks has yet to beestablished.

Most of the series investigating the results of these twoendoscopic techniques comprised only small numbers ofpatients, and there have been no prospective randomizedtrials comparing the two methods. Several authors have re-ported small series of patients with successful resolution ofbiliary fistulae following electrosurgical division of the am-pullary sphincter [7, 8, 18, 27, 28]. In addition, Geenen et al.found a significant reduction in the common bile duct toduodenal pressure gradient at 12 months following endo-scopic sphincterotomy [14]. No studies, however, have in-vestigated the immediate pressure changes following endo-scopic sphincterotomy.

It is our belief that the results of the Geenen study do notreflect the early changes following endoscopic sphincterot-omy. The local inflammatory process that occurs followingelectrosurgical division of the sphincter may prevent imme-diate biliary decompression. This hypothesis is supportedby our previous work, which identified no significant acutereduction in common bile duct pressures following sphinc-terotomy as compared to baseline in a canine model [37].

The use of biliary endoprostheses has been recom-mended by other investigators as a more effective methodfor equilibrating the pressures between the biliary tree andthe duodenum than sphincterotomy alone [4, 15, 16, 19, 30,34, 35, 37]. In addition, Mortensen and Kruse argued thatendoscopic stent placement was superior to endoscopicsphincterotomy because it preserves the sphincter of Oddi.The complication rate from stent placement was very low intheir report; there was only one case of cholangitis [23].Smith et al. documented the successful management of sev-eral high-volume biliary cutaneous fistulae, which healedpromptly after placement of biliary stents [30]. Traverso etal. also prefer endoscopic stent placement for the manage-ment of cystic duct leaks following cholecystectomy. Theyreported that it allowed for successful decompression of thebiliary tree with almost immediate amelioration of the bil-iary fistula [33]. Moulton et al. presented three cases ofbiliary leaks following pediatric liver trauma that were allmanaged successfully with ERCP and transampullary bili-ary decompression [24].

The major disadvantage to biliary stent placement is thatit requires a second endoscopic procedure to remove thestent. One alternative to stent placement is the use of anasobiliary tube [2, 5, 9, 22]. These tubes can be removedwithout a repeat endoscopy, although a follow-up cholan-giogram is usually performed. The disadvantages of naso-biliary tubes include patient discomfort, fluid losses, elec-trolyte disturbances, and possibly prolonged hospitalization.Complications of endoprosthesis placement include biliaryobstruction, cholangitis, stent migration, and pancreatitis.

The major complications of endoscopic sphincterotomycan be divided into immediate and long-term risks. Theimmediate complications of endoscopic sphincterotomy in-clude bleeding, duodenal perforation, and pancreatitis. Thelong-term complications of endoscopic sphincterotomy areas yet unknown. However, the postsphincterotomy stenosisrate may be as high as 6–13% in patients followed for >10years [6]. In addition, the use of endoscopic sphincterotomy

in patients with small- or normal-caliber bile ducts can leadto higher complication rates, as has been reported by Sher-man et al. [29]. The placement of 10-Fr biliary stents, how-ever, does not routinely require a sphincterotomy or papil-lotomy.

In conclusion, biliary stenting significantly reduces thetime to resolution of cystic duct leaks as compared tosphincterotomy in this canine model. Although the samplenumbers are small and variations in the severity of fistulaeleading to statistical bias may exist due to different baselineintraductal pressures, cystic duct length, and CBD diameter,the results obtained in this study support the use of biliaryendoprostheses rather than endoscopic sphincterotomy inthe management of simple biliary fistulae.

Acknowledgments.We are grateful to Wilson-Cook Medical Inc., Winston-Salem, NC, USA, for their support of this work. We also thank Jane Dostaland Brian Dunkin, M.D., for their assistance in the preparation of thismanuscript.

References

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2. Barthel JS, Sastri SV, Landsbaum C (1989) Closure of cystic ductstump leak by nasobiliary tube drainage. J Clin Gastroenterol 11:574–577

3. Bezzi M, Silecchia G, Orsi F, Materia A, Salvatori FM, Fiocca F,Fantini A, Basso N, Rossi P (1995) Complications after laparoscopiccholecystectomy: coordinated radiologic, endoscopic, and surgicaltreatment. Surg Endosc 9: 29–36

4. Binmoeller KF, Katon RM, Shneidman R (1991) Endoscopic manage-ment of postoperative biliary leaks: review of 77 cases and report oftwo cases with biloma formation. Am J Gastroenterol 86: 227–231

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8. Del Olmo L, Merono E, Moreira VF, Garcia T, Garcia-Plaza A (1988)Successful treatment of postoperative external biliary fistulas by en-doscopic sphincterotomy. Gastrointest Endosc 34: 307–309

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12. Edelman DS (1994) Bile leak from the liver bed following laparoscop-ic cholecystectomy. Surg Endosc 8: 205–207

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14. Geenen JE, Toouli J, Hogan WJ, Dodds WJ, Stewart ET, Mavrelis P,Riedel D, Venu R (1984) Endoscopic sphincterotomy: follow-upevaluation of effects on the sphincter of Oddi. Gastroenterology 87:754–758

15. Goldin E, Katz E, Wengrower D, Kluger Y, Haskel L, Shiloni E,Libson E (1990) Treatment of fistulas of the biliary tract by endoscopicinsertion of endoprostheses. Surg Gynecol Obstet 170: 418–423

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17. Gilliland TM, Traverso LW (1990) Modern standards for comparisonof cholecystectomy with alternative treatments for symptomatic cho-lecystectomies with emphasis on long-term relief of symptoms. SurgGynecol Obstet 170: 39–44

18. Hsu D (1987) Endoscopic sphincterotomy in the management of bil-iary-cutaneous fistula. Am J Gastroenterol 82: 1078–1080

19. Janardhanan R, Brodmerkel GJ Jr, Turowski P, Gregory DH, AgrawalRM (1986) Endoscopic retrograde cholangiopancreatography in thediagnosis and management of postcholecystectomy cystic duct leaks.Am J Gastroenterol 81: 474–476

20. Kaufmann SL, Kadir S, Mitchell SE, Chang R, Kinnison ML, Cam-eron JL, White RI Jr (1985) Percutaneous transhepatic biliary drainagefor bile leaks and fistulas. AJR 144: 1055–1058

21. Klotz HP, Schlumpf R, Largiader F (1992) Injury to an accessory bileduct during laparoscopic cholecystectomy. Surg Laparosc Endosc 2:317–320

22. Leung JWC, Chung SCS, Sung JY, Metreweli C (1988) Endoscopicmanagement of postoperative biliary fistula. Surg Endosc 2: 190–193

23. Mortensen J, Kruse A (1992) Endoscopic management of postopera-tive bile leaks. Br J Surg 79: 1339–1341

24. Moulton SL, Downey EC, Anderson DS, Lynch FP (1993) Blunt bileduct injuries in children. J Pediatr Surg 28: 795–797

25. Mueller PR, Ferrucci JT Jr, Simeone JF, Cronan JJ, Wittenberg J, NeffCC, van Sonnenberg E (1983) Detection and drainage of bilomas:special considerations. AJR 140: 715–720

26. Mullen JP, Carr RE, Rupnik EJ, Knapp RW (1976) 1000 cholecys-tectomies, extraductal palpation and operative cholangiography. Am JSurg 131: 672–675

27. O’Rahilly S, Duignan JP, Lennon JR, O’Malley E (1983) Successfultreatment of a post-operative external biliary fistula by endoscopicpapillotomy. Endoscopy 15: 68–69

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doscopic treatment of biliary tract fistulas. Gastrointest Endosc 35:490–498

29. Sherman S, Ruffolo TA, Hawes RH, Lehman GA (1991) Complica-tions of endoscopic sphincterotomy: a prospective series with empha-sis on the increased risk associated with sphincter of Oddi dysfunctionin nondilated bile ducts. Gastroenterology 101: 1068–1075

30. Smith AC, Schapiro RH, Kelsey PB, Warshaw AL (1986) Successfultreatment of nonhealing biliary-cutaneous fistulas with biliary stents.Gastroenterology 90: 764–769

31. Soper NJ (1991) Laparoscopic cholecystectomy. Curr Probl Surg 28:587–655

32. Southern Surgeons Club (1991) A prospective analysis of 1518 lapa-roscopic cholecystectomies. N Engl J Med 324: 1073–1078

33. Traverso LW, Kozarek RA, Ball TJ, Brandabur JJ, Hunter JA, JollyPC, Patterson DJ, Ryan JR, Thirlby RC, Wechter DG (1993) Endo-scopic retrograde cholangiopancreatography after laparoscopic chole-cystectomy. Am J Surg 165: 581–586

34. Vitale GC, Stephens G, Wieman TJ, Larson GM (1993) Use of endo-scopic retrograde cholangiopancreatography in the management of bil-iary complications after laparoscopic cholecystectomy. Surgery 114:806–814

35. Woods MS, Shellito JL, Santoscoy GS, Hagan RC, Kilgore WR, Tra-verso LW, Kozarek RA, Brandabur JJ (1994) Cystic duct leaks inlaparoscopic cholecystectomy. Am J Surg 168: 560–565

36. Woods MS, Traverso LW, Kozarek RA, Tsao J, Rossi RL, Gough D,Donohue JH (1994) Characteristics of biliary tract complications dur-ing laparoscopic cholecystectomy. Am J Surg 167: 27–32

37. Youngelman DF, Marks JM, Ponsky T, Ponsky JL (1997) Comparisonof bile duct pressures following sphincterotomy and endobiliary stent-ing in a canine model. Surg Endosc 11: 126–128

38. Zucker KA, Bailey RW, Gadacz TR, Imbembo AL (1991) Laparo-scopic guided cholecystectomy. Am J Surg 161: 36–44

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EndoScope: world literature reviews

Original articles from a wide range of international surgical journals are selected by our editors and presentedhere as a structured summary and critical review.EndoScopeserves as a quick and comprehensive surveyof the expansive endoscopic literature from all the corners of the globe.

Common bile duct exploration andlaparoscopic cholecystectomy: role ofintraoperative ultrasonography

Santambrogio, R, et alJ Am Coll Surg (1997) 185: 1–7

The role of laparoscopic ultrasound (LUS) in determiningwhether a patient has choledocholithiasis during a laparo-scopic cholecystectomy (LC) was prospectively studied.Two hundred sixteen consecutive patients with symptom-atic gallstones were enrolled in the study. All underwent astandard preoperative algorithm including ultrasonographyand measurements of liver function tests on the working daybefore operation. Patients at high risk for common bile duct(CBD) stones underwent ERCP before LC. Laparoscopicultrasonography examination during cholecystectomy wasroutinely performed to identify stones unsuspected preop-eratively. One hundred seventy-seven (82%) of the patientswere determined to be low risk for choledocholithiasis and39 patients (18%) were at high risk and had preoperativeERCP. In 17 patients (43.5%) CBD stones were found, andin 16 patients (41%) they were removed by endoscopicsphincterotomy.

In all patients LUS documented the intra- and extrahe-patic ducts, but the distal tract of the CBD was not wellvisualized in eight cases. Small stones were found in theCBD of eight patients. A subsequent CBD exploration orintraoperative cholangiogram confirmed the diagnosis in allbut one patient. Retained CBD stones were found in twopatients during the follow-up period. An endoscopic sphinc-terotomy was performed in those patients successfully.

Based on these data the authors suggest that laparoscop-ic ultrasonography may be a real alternative to cholangiog-raphy during laparoscopic cholecystectomy. The authorsalso point out that considerable ultrasonographic experienceis required for LUS to be performed successfully.Comments: This paper is an interesting evaluation of lap-aroscopic ultrasonography to determine choledocholithiasis.It would have been beneficial if the study had looked at therole of laparoscopic ultrasound in delineating the anatomyto prevent CBD injuries. The paper did not allude to anyadvantages of laparoscopic ultrasonography vs cholangiog-raphy to justify learning this new skill for the purpose ofdetecting choledocholithiasis.

Randomized, prospective, single-blindcomparison of laparoscopic versussmall-incision cholecystectomy

Majeed, AW, et alLancet (1996) 347: 989–994

A prospective randomized comparison of elective laparo-scopic and small-incision cholecystectomy in 200 patientsinvolving four surgeons was conducted in Sheffield, UK.All subjects had symptomatic gallstones confirmed by ul-trasonography and randomized for elective cholecystectomyby either method. The four participating surgeons had aminimum of 40 laparoscopic cholecystectomies each as ei-ther the principal operator or assistant, and no comment ismade about their small-incision experiences. The small-incision method requires a high transverse sub-xiphoid in-cision over the junction of the cystic duct and common bileduct. The length of the incision is tailored to individualcases (median of 7 cm). Standard instruments are used forthe ‘‘fundus-last’’ dissection and, finally, as in laparoscopy,all cases are accompanied by intraoperative cholangiogram.

The authors report that more time was required for lap-aroscopic cholecystectomies when compared to the small-incision procedure (median 65 min vs 40 min, respectively,and including cholangiogram time). They found no differ-ence between the groups for hospital stay, time back towork, and time to full activity.

Of the 205 meeting the criteria for elective cholecystec-tomy between 1992 to 1995, only five cases were elimi-nated—because the patients refused to be randomized, he-patic metastasis, or cirrhosis was present. Although patientselection is randomized, the four surgeons participating inthe study were still able to affect the outcome of thestudy—a design flaw that is always an inherent problem inthis type of study. The longer time reported for the laparo-scopic procedure may not be a significant finding, as it cancertainly be shortened. Finally, the complication reported isnotable for one bile duct injury only in the laparoscopicgroup, which was fortunately identified after an intraopera-tive cholangiogram. An interesting observation is that theoverall conversion rate in the laparoscopic group turned outto be 20%—a figure that is much higher than reported in theliterature.

Certainly, the authors have shown that for the surgeonswell adapted to the small-incision technique, similar post-

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operative recovery results can be achieved as with the lap-aroscopic method. However, the bias for or against the pro-cedure is impossible to remove from the surgeons in thestudy, and therefore true randomization remains question-able.

Laparoscopic or open splenectomy forhematologic disease: which approachis superior?

Friedman, RL, et alJ Am Coll Surg (1997) 185: 49–54

A retrospective review of 137 patients who underwent lap-aroscopic (LS) and open splenectomy (OS) at the Cedars-Sinai Medical Center in Los Angeles, California, was per-formed. The study was performed to compare safety, out-come, and costs of laparoscopic and open splenectomy fora variety of hematologic diseases. Diagnosis, age, gender,operative time, blood loss, splenic weight, time to resump-tion of oral diet, postoperative hospital stay, morbidity,mortality, and costs were analyzed by multivariate statisti-cal analysis.

Patients who underwent laparoscopic splenectomy hadsignificantly shorter hospital stay and time to resumption ofan oral diet (p < 0.01). Operative costs were higher, al-though the total direct costs were not. Idiopathic thrombo-cytopenic purpura patients had earlier resumption of an oraldiet after LS, shorter postoperative stay, and comparableOR time. Five patients (7%) were converted, with outcomessimilar to OS except for greater operative time and cost.Grade II complications occurred in three LS and four OSpatients; grade III in three OS patients; and grade IV in twoOS patients. There were two major complications of LS andeight of OS, with two deaths. Multivariate analysis revealedthat operative time and time to resumption of oral intakewere significantly related to age, diagnosis, operative tech-nique, and splenic weight. The duration of postoperativehospitalization was related to operative technique, splenicweight, and major complications. Costs (direct and opera-tive) were related to age, splenic weight, and major com-plications, but not to operative technique.

The authors concluded that LS results are influenced bysplenic weight, disease, and age. Splenic weight appears tobe the crucial determinant of operative time and length ofhospitalization. LS is a superior treatment for patients withidiopathic thrombocytopenic purpura and patients withsmall spleens.Comments: This is a very well organized review compar-ing laparoscopic and open splenectomy. However, we mustkeep in mind that this is a retrospective review and patientselection for open or laparoscopic splenectomy was basedon surgeon preference as well as time of resumption of oralintake and length of hospitalization. Perhaps a large pro-spective randomized trial comparing laparoscopic and opensplenectomy might draw the same conclusions.

Endoscopic monitoring of operativeprocedures during cardiac surgery

Miyagawa, H, et alSurg Today Jpn J Surg (1997) 27: 434–438

This is a case report of five patients who underwent intra-operative monitoring using an endoscope video system dur-ing open heart surgery. The scope was used to visualize (1)the inside of the aorta to identify tears during hemiarchreplacement for an acute aortic dissection, (2) an anastomo-sis and debris via a left ventriculotomy for a left ventricleaneurysm, (3) the right ventricular outlet tract and locationof an atrial septal defect (ASD) in a patient with an ASDand a right ventricular outlet tract resection, (4) the anasto-mosis during a coronary artery bypass graft (CABG) in a14-year-old with Kawasaki’s disease, and (5) any leakageduring a mitral valve plasty and aortic valve replacement.The authors concluded that an endoscopic video monitoringsystem is useful not only for thoracic surgery but also forcardiac surgery.Comments: Using an endoscope for magnification duringCABG seems much more cumbersome than directly view-ing the anastomosis using magnifying glasses. Perhaps anendoscope may be useful in viewing lesions that are intra-cardiac and otherwise difficult to view directly. The newfield of minimally invasive coronary artery surgery willdoubtless engender many such novel developments.

A video-assisted thoracoscopic surgicaltechnique for interruption of patentductus arteriosus

Tsuboi, H, et alSurg Today Jpn J Surg (1997) 27: 439–442

This study describes a technique for closure of a patentductus arteriosus (PDA) using video-assisted thoracoscopicsurgery (VATS). Five patients with a mean age of 3 yearsand mean weight of 13.7 kg were operated. Under generalanesthesia, two 10-mm trocars and two or three 5-mm tro-cars were inserted through the left thoracic wall. A videocamera and specially designed surgical tools including scis-sors, dissectors, and a clip applicator were introduced. Theductus was dissected, and two titanium clips were applied tointerrupt the ductus completely. Closure of the PDA wassuccessful in all patients. The only complication was in onepatient who developed hoarseness for 2 weeks postopera-tively. The hospital stay ranged from 7 to 12 days. Theauthors concluded that VATS is a safe and effective tech-nique for achieving closure of PDA.Comments: The paper describes a technique which seemsto be an excellent alternative to a classical left thoracotomy.

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Further experience with this procedure and larger studies inthe literature might make this procedure the preferred tech-nique for closure of a PDA.

A comparison of open and laparoscopiccholecystectomy for patients with cirrhosis

Saeki, H, et alSurg Today Jpn J Surg (1997) 27:411–413

This is a retrospective study of 13 patients who underwentcholecystectomy for gallstones over a 6-year period: Sevenhad laparoscopic cholecystectomy (LC) and six had opencholecystectomy (OC). No statistical differences were ob-served in the duration of surgery or the intraoperative bloodloss between the two groups; however, the C-reactive pro-tein level in the serum was significantly higher in the OCgroup than in the LC group. LC was followed by a signifi-cantly shorter hospital stay (p < 0.05) and earlier resumptionof a normal diet (p < 0.05) in comparison to OC. All of thepatients who underwent OC had an uneventful clinicalcourse; however, 9 of the patients who underwent LC suf-fered from intractable ascites postoperatively. The differ-ence in the cost of hospitalization between the two groupswas not statistically significant. The authors conclude thatthe therapeutic significance of performing LC in patientswith cirrhosis should be assessed after carefully evaluatingall factors including mortality, morbidity, and cost effec-tiveness.Comments:This is a retrospective study with a very smallnumber of patients. No conclusions can be drawn from thispaper. The authors stated that caution should be exercisedwhen selecting laparoscopic cholecystectomy for patientswith cirrhosis because one patient in the group developedsevere ascites leading to liver failure and death 5 monthsafter operation. But one may not generalize because nostatistical significance is possible with such a small numberof patients. The authors did not propose any hypothesis as towhy they think that there would be any difference betweencomparing LC and OC in patients with and without cirrho-sis.

Treatment of colovesical fistulas bylaparoscopic surgery: report of five cases

Nassiopoulos, K, et alDig Surg (1997) 14: 56–60

This study is a case report on five cases of colovesicalfistulas that were treated by laparoscopic surgery. In allcases the clinical picture was characterized by pneumaturiaand signs of diverticular disease of the sigmoid. Barium or

water-soluble contrast enema, computed tomography, andcystoscopy were used to establish the diagnosis. All patientswere managed by a ‘‘one-stage’’ excision of the colovesicalfistula combined with simultaneous colon resection using alinear stapler cutter. The mean operative time was 3 h 50min. There were no reports of any complications and fulloral feeding was initiated on the 3rd postoperative day. Themean total hospital stay was 13 days. The authors concludedthat a ‘‘one-stage’’ excision of colovesical fistulas com-bined with simultaneous colon resection is feasible laparo-scopically, but the training and experience of the surgeonare essential for the success of this method.Comments:This article was a very well written case report.It would be interesting to know how low down the sigmoidcolon was resected. It may be difficult to use the staplers toresect the sigmoid colon down to the peritoneal reflection toprevent recurrence of the diverticular disease.

Emergency minilaparotomy cholecystectomyfor acute cholecystitis: prospectiverandomized trial—implications for thelaparoscopic era

Assalia, A, et alWorld J Surg (1997) 21: 534–539

This article is a prospective controlled trial comparing mini-cholecystectomy (MC) in cases of acute cholecystitis toconventional cholecystectomy (CC). Sixty consecutive pa-tients with acute cholecystitis were prospectively random-ized to undergo MC (30 cases) or CC (30 cases). The twogroups were well matched with regard to age, sex, weight/height index, previous upper abdominal surgery, andAPACHE II scores. The mean length of incision was 5.5 cmin the MC group compared to 13.5 cm in the cc group.There was no signicant difference with regard to operativetime, operative difficulty on a 1 to 10scale, and complica-tion rate. Significantly lower analgesia requirements werenoted in the MC group: 27.5 ± 14.6 mg of morphine sulfatecompared to 44.5 ± 13.2 mg in the CC group (p < 0.001).Twenty-two patients (73%) in the MC group were reportedto return to normal daily activities 2 weeks after the opera-tion, compared to only 12 (40%) in the CC group (p 40.0028). The authors concluded that MC is safe and appli-cable as an emergency procedure for acute cholecystitis. Itis superior to CC in terms of convalescence and cosmesis.The results of MC in the setting of acute cholecystitis com-pare favorably with the published results of laparoscopiccholecystectomy (LC).Comments:This study is a well-designed prospective con-trolled study. One thing which was not controlled for in thestudy was the number of days it took to go to the operatingroom from the time of onset of symptoms, which has pre-viously be shown by Garber et al (Surg Endosc[1997] 11:347–350) to affect the conversion rate and morbidity for

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laparoscopic cholecystectomy. The conclusion that MCcompares favorably with LC is not completely accurate. Theaverage length of stay of 3.1 ± 1.0 days is higher than otherstudies on laparoscopic cholecystectomy for acute chole-cystitis. Perhaps a prospective study comparing MC to LCwould determine if MC is comparable to LC.

Early postoperative results of a prospectiveseries of laparoscopic vs. open anteriorresections for rectosigmoid cancers

Goh, YC, et alDis Colon Rectum (1997) 40: 776–780

This study prospectively compared postoperatively laparo-scopic (LAR) with open (OAR) anterior resection in pa-tients with rectosigmoid cancer. Forty consecutive patientswere divided into two groups. Twenty patients without apalpable abdominal mass under anesthesia were subjectedto LAR, and 20 patients with a palpable mass underwentOAR. Median lengths of distal margin of clearance beyondthe tumor were 4 cm and 4.5 cm in the LAR and OARgroups, respectively. Median numbers of lymph nodes har-vested were 20 and 19 for the LAR and OAR groups, re-spectively. Median operating times were 90 min and 73 minin the LAR and OAR groups, respectively. Blood loss was50 ml in both groups. There was no intraoperative compli-cation in either group, and no laparoscopic patient was con-verted to an open procedure. Median length of extractionsite incision in the LAR group was 5.5 cm and the length ofincision in the OAR group was 18 cm (p < 0.002). Medianlength of follow-up was 8 months for the LAR group and 10months for the OAR group. The mean postoperative stay forthe LAR group was 5 days and 5.5 days for the OAR group.The authors concluded that there were no significant differ-ences between the two groups with regard to duration ofparenteral analgesia, starting of fluid and solid diet aftersurgery, time to first bowel movement, or time to dischargefrom the hospital.Comments: This article brings attention to a very contro-versial area in laparoscopic surgery: colon cancer. Thisstudy reported no evidence of port site recurrence with afollow-up of only 8 months; however, the incidence of portsite recurrence ranges from 0 to 4.5% in the literature.Given the results of this paper indicating no improvement inpostoperative course for patients with LAR, one shouldthink carefully about affecting the outcome of a potentiallycurable disease. Currently there are large multicenter studieslooking at this issue. The authors certainly seem to be adept,as they are able to complete the procedure in an expeditiousfashion.

Laparoscopic cholecystectomy for acutecholecystitis: prospective trial

Eldar, S, et alWorld J Surg (1997) 21: 540–545

This is a prospective study to determine the indications forand the optimal timing of laparoscopic cholecystectomy(LC) following the onset of acute cholecystitis. It alsoevaluates preoperative and operative factors associated withconversion from LC to open cholecystectomy (OC) in thepresence of acute cholecystitis. The study consisted of 130patients, of which 93 (72%) underwent successful LC and37 (28%) needed conversion to OC. The conversion rate ofacute gangrenous cholecystitis (49%) was significantlyhigher than that for uncomplicated acute cholecystitis(4.5%) and for hydrops (28.5%) and empyema of the gall-bladder (28.5%). Patients with an operative delay of 96 h orless from the onset of acute cholecystitis had a conversionrate of 23%, whereas a delay of more than 96 h was asso-ciated with a conversion rate of 47% (p 4 0.022). Thecomplication rate was 8.5% in the LC group and 27% in theconverted group. Patients over 65 years of age, with a his-tory of biliary disease, a nonpalpable gallbladder, WBCcount over 13,000/cc, and acute gangrenous cholecystitiswere independently associated with a high LC conversionrate; male patients, finding large bile stones, serum bilirubinover 0.8 mg/dl, and WBC count over 13,000/cc were inde-pendently associated with a high complication rate follow-ing laparoscopic surgery with or without conversion. Theauthors concluded that LC can be performed safely for acutecholecystitis, with acceptably low conversion and compli-cation rates. Different forms of cholecystitis carry variousconversion and complication rates in selected cases. LC foracute cholecystitis should be performed within 96 h of theonset of disease. Predictors of conversion and complicationsmay be helpful when planning the laparoscopic approach toacute cholecystitis.Comments:This is a large prospective study on acute cho-lecystitis and has conclusions similar to those previouslyreported by Garber et al. (Surg Endosc[1997] 11: 347–350)in that the conversion rate is dramatically different within 4days of onset of symptoms. The conversion rate for less than96 h of symptoms was much higher in this paper, 23%, ascompared to 3.6% reported by Garber et al. The experienceof the surgeons was not well defined, and perhaps thisplayed a role in the difference. Concerning the higher mor-bidity rate after conversion in this study, a posible bias is theassociation of several comorbid factors and the fact thatconversion has been performed in the most difficult cases.

Reviewers for this issue: S. M. Garber, J. M. Sackier,F. Chae.

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Common bile duct injuries during laparoscopic cholecystectomy thatresult in litigation

B. J. Carroll, M. Birth, E. H. Phillips

Department of Surgery, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048, USA

Received: 3 April 1997/Accepted: 5 July 1997

AbstractBackground: Iatrogenic common bile duct injury is theworst complication of laparoscopic cholecystectomy. Thegoal of this study is to increase awareness of the problemand educate surgeons about the consequences of these in-juries.Methods:A total of 46 bile duct injuries were analyzed byreview of medical records, cholangiograms, videotapes, andsurgeon statements. All cases were involved in malpracticelitigation.Results:All types of injuries were represented. There were15 transections, 11 excisions, 6 lacerations, 8 clip impinge-ments, 3 burns, 2 bile leaks, and 1 cystic duct leak. In all,72% of these injuries occurred in elective cases in whichthere was no acute inflammation. Cholangiograms wereperformed in 16 cases, but they were misinterpreted in 11 ofthem. Injury type and severity was similar in patients withand without cholangiography. A total of 80% of these in-juries were not detected at the initial surgery. The averagedelay in diagnosis was 10 days. Complications were worsein patients with delayed diagnosis. Primary surgeons hadless successful outcomes from repairs than referral surgeons(27% versus 79%). In 86% of cases, litigation was resolvedin favor of plaintiffs by settlement or verdicts. The averageaward was $214,000.Conclusions:Factors that predispose to lawsuits includetreatment failures in immediately recognized injuries, com-plications that result from delays in diagnosis, and misin-terpretation of abnormal cholangiograms. Injury preventioncan be improved by increased awareness of common mis-takes. Improved cholangiographic technique and interpreta-tion should decrease injury severity, delays in diagnosis,and subsequent morbidity.

Key words: Laparoscopic cholecystectomy — Injuries —Common bile duct — Litigation

The benefits of laparoscopic cholecystectomy have beenachieved against the backdrop of an increased incidence ofbile duct injuries. A total of 98 studies have examined theoutcome of 78,747 laparoscopic cholecystectomies. The in-cidence of bile duct injuries ranged from 0.36% to 0.47%[6]. However, selection bias, nonreporting of injuries, and alack of long-term follow-up have led to an underestimationof the true incidence of injuries.

This study was undertaken to increase the awareness ofthe types, consequences, and financial impact of laparo-scopic bile duct injuries that result in litigation.

Materials and methods

We reviewed 46 cases involving bile duct injury sustained during laparo-scopic cholecystectomy, which were supplied by 41 attorneys. Each casewas already involved in malpractice litigation. Complete medical records,intraoperative cholangiograms (obtained in 16 cases), and postoperativecholangiograms were studied. Videotape documentation of the operationwas available in six cases.

Results

The injuries occurred between September 1990 and March1996. There were 41 women and five men. Their averageage was 38 years. The average for women was 37 years; formen, it was 50 years.

Bile duct injuries occurred whether the operations wereperformed by inexperienced or experienced laparoscopicsurgeons. However, data regarding the surgeon’s prior ex-perience were available in only 27 cases. Seven injuriesoccurred in the surgeons’ first 10 cases, 11 within the sur-geon’s first 50 cases, four between 50 and 100 cases, andfive injuries occurred after experience with >100 cases.

All types of bile duct injuries were represented in these46 cases. There were 15 transections, 11 excisions, 6 lac-erations, 8 cases of clip impingement, three electrocauteryburns, two bile leaks from the liver bed, and one cystic ductleak. The Bismuth level and injury type is shown in Table1.

Intraoperative factors and etiologies for injuries weredetermined by a review of records, cholangiograms, videodocumentation, and reoperative findings. Thirteen injuries

Presented at the annual meeting of the Society of American Gastrointes-tinal Endoscopic Surgeons (SAGES), San Diego, California, USA, 20-21March 1997Correspondence to:B. J. Carroll, 8635 West 3rd Street, Suite 795 West,Los Angeles, CA 90048, USA

Surg Endosc (1998) 12: 310–314

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occurred in the presence of acute inflammation (severe inseven cases, moderate in six cases) and 33 in conjunctionwith chronic scarring (severe in one case, moderate in 14cases, minimal in 18 cases).

In 25 of 46 cases (54%), no problem was recorded in theoperative report or patient chart following laparoscopic cho-lecystectomy. In nine cases (20%) there was chronic scar-ring, adhesions, and thickening of the hilar tissue that wasretrospectively thought to have contributed to injury. Ashort cystic duct was implicated by the operating surgeoncausally in eight cases (17%), but this fact was noted onlyafter recognition of the injury. Excessive bleeding was re-ported in three cases. In two cases, surgeons confused thecommon bile duct for a large cystic duct. In two additionalcases, the common hepatic duct was confused for an acces-sory duct draining directly into the gallbladder after thecommon bile duct had been mistaken for a cystic duct andhad been transected below the junction with the cystic duct.The mechanisms of injury were as follows:

Inadequate Calot dissection/confusion of normalanatomy

misidentification of CBD as cystic duct (17)cystic clips impinging on CBD (3)misidentification of CHD (2)

Misinterpretation of cholangiographyBlind clipping/cauterization near hilumUnknown/unrecognizedFailure to recognize Luschka duct

22

11562

In 37 patients (80%), bile duct injuries were not imme-diately recognized during the initial surgery. In 16 patientswho had intraoperative cholangiography, only two (13%)had immediate recognition of injury. Also, cholangiographywas not associated with decreased injury severity in thisstudy. However, 11 of 16 patients (69%) had abnormal cho-langiograms that were misinterpreted intraoperatively. Ifthese 11 cholangiograms had been interpreted properly, theinjuries would have been discovered immediately, and moresevere excisional injuries could have been prevented (Figs.1 and 2). Therefore, in 13 cases (81%), the surgeon couldhave identified the injury at the time of LC. In addition,attempts at cholangiogram were aborted in two cases. Con-versely, in 23 of 30 cases (77%) where cholangiographywas not performed, surgeons failed to recognize injuriesintraoperatively.

The cholangiography errors were as follows:

Nonvisualized hepatic ductExtravasation of uncertain originAborted/incomplete procedure

641

In the 37 patients with delayed recognition of bile ductinjury, the average delay was 10 days (range, 3–31 days).The presenting symptoms were as follows:

Elevated liver function testsPain in abdomen/shoulderNausea/vomitingFeverIleusLeukocytosis

34 (92%)32 (87%)17 (46%)9 (24%)6 (16%)5 (14%)

The average postoperative bilirubin in patients with bileduct injuries was 4.5 mg% (range, 1–19). In 27 of 37 pa-tients (73%) with a diagnosis of bile duct injury that wasmade postoperatively, additional delays resulted from diag-nostic and treatment failures. Endoscopic retrograde chol-angiograms were unsuccessful or misinterpreted in six cases

Table 1. Classification of injuries

Bismuthlevel

Injury type

Transection Excision Laceration Impingement Burn Totala

1 1 0 1 2 1 52 10 7 3 6 0 263 1 3 1 0 1 64 3 1 1 0 1 0

a Plus (one) cystic leak and two Luschka leaks not classified by Bismuth level.

Fig. 1. Intraoperative cholangiogram demonstrating nonvisualization ofhepatic duct performed prior to common bile duct transection.

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(16%). Biloma was dismissed as a duct of Luschka leak orminor cystic duct leak in six cases. Symptoms were misdi-agnosed as common duct stone or ulcer in five patients.Subhepatic fluid collection was dismissed as irrigant orblood in four cases. The patient initially refused testing infour instances, and shoulder or abdominal pain was notevaluated in two patients.

The injuries were treated as shown in Table 2. Success-ful repair of the injury by the primary surgeon occurred inonly six of 22 cases (27%). Repair by a more experiencedsurgeon at a tertiary center with special expertise in bileduct repair occurred in 19 of 24 cases (79%). All primaryend-to-end repairs (seven cases) were done by the primarysurgeons; the success rate was 43%. Three end-to-end re-pairs were performed during the initial surgery, and all ofthese strictured within 6 months. Three end-to-end repairswere performed in the postoperative period (days 2, 4, and51) and have been successful to date. One end-to-end repairperformed 59 days after injury strictured. The reason for thefailure of repairs performed by primary surgeons was stric-ture or anastomotic leak in 14 of 16 cases (88%). Immediaterepair was successful in only one of eight repairs, whereasrepairs performed for injuries diagnosed postoperativelywere successful in 21 of 25 cases (84%). These data prob-ably reflect the type of repair and the experience of theoperator rather than the timing of the repair.

Complications other than the initial bile duct injury oc-curred in most patients. Eight of the nine patients (89%)who had immediate recognition and attempted repair of theduct injury had postoperative complications of either leak orstricture resulting in cholangitis. Twenty-three of the 37patients (62%) who had delayed recognition of injury suf-

fered complications including 12 leaks/strictures, three ab-scesses, three small bowel obstructions, one wound infec-tion, one dehiscence, one ventral hernia, one gastrointestinalbleed, one acute respiratory distress syndrome (ARDS), andone death.

There was one death due to bile peritonitis and sepsisthat resulted from a cystic duct leak. This 63-year-old pa-tient had undergone reexploration with drainage on the 7thpostoperative day.

To date, litigation has been resolved in 30 cases.Twenty-one cases were settled out of court, with an averagesettlement of $221,000 (range, $30,000–1,300,000). In fivecases, the plaintiffs prevailed at trial, with an average awardof $214,000 (range, $125,000–240,000). In four cases, therewas a defense jury verdict. In three of four defense verdicts,the injury was caused by clip impingement. The fourth de-fense verdict involved an excision of a segment of the com-mon hepatic duct in an inflamed acute case without chol-angiography. There was a delayed diagnosis, but repair at atertiary center proved successful.

Discussion

The spectrum of iatrogenic bile duct injuries ranges fromminimal to life-threatening. Since the cases reviewed rep-resent only patients who were involved in litigation, they arenot necessarily representative of all bile duct injuries nor thefrequencies of those injuries. Nevertheless, all major injurytypes, ranging from clip impingements to excision of theentire extrahepatic biliary tree, are represented. Injuries di-agnosed and treated at the time of injury as well as injuriesidentified and treated later by the treating surgeon and ex-perts are represented.

Some patterns seem to predispose to lawsuits. Most ofthese patients had failures of immediate repairs or compli-cations following delays in diagnosis. From a medical-legalstandpoint, 86% of cases in this study were resolved in favorof plaintiffs through settlements or verdicts.

It has been previously suggested that the high rate ofbiliary injury associated with laparoscopic cholecystectomyis the result of the learning curve [2, 3]. However, otherinvestigators have noted an ongoing problem well past thelearning period [4, 7]. Nine injuries in this study occurredafter the surgeon’s 50th case, and five of these were after the100th case (including ductal transections and excisions).Clearly, no surgeon is immune from the risk of bile ductinjury, and no case is simply routine.

Technical errors were the primary cause of these inju-ries. Injuries resulted from misidentification of normal

Fig. 2. Intraoperative cholangiogram showing extravasated contrast per-formed after a common hepatic duct injury.

Table 2. Treatment of injuries

Type of repair No. of cases Success (%)

Choledocho-/hepaticojejunostomy 29 11 (44)Primary end-to-end repair 7 3 (43)Closure with T-tube 4 3 (75)Drain only 3 N/ARemove clip on CBD 1 1 (100)Stent only 1 1 (100)Ligation of CBD (in error) 1 N/A

N/A, not applicable.

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anatomy in 48% of cases. Seventy-two percent of injuriesoccurred in nonacute cases. The majority of injuries resultedwhen the common bile duct was mistaken for the cystic ductdue to inadequate dissection in the triangle of Calot, failureto identify the underside of the gallbladder, and possibly inpart to excessive upward tension placed on the duct. Othertechnical errors, such as cautery injury and blind or closeclipping to the common duct, occurred in 11%. We recom-mend using blunt dissection starting posterolaterally at thepresumed cystic duct–gallbladder junction, avoiding cau-tery, sharp dissection, and clipping until the triangle ofCalot and the underbelly of the gallbladder are fully ex-posed both laterally and medially.

All injury types (lacerations, excisions, burns, and clipimpingements) were seen even when intraoperative cholan-giography was done. Despite the aid of cholangiography,misinterpretation of radiographic evidence of bile duct in-jury occurred frequently. The most common cholangio-graphic abnormalities associated with bile duct injurieswere nonvisualized intrahepatic ducts and contrast extrava-sation. A cholangiogram must show contrast in the right andleft hepatic ducts and the duodenum. Extravasation of con-trast can mean that an injury is present. Intraoperative re-view of cholangiograms by an experienced radiologist canbe helpful.

Although the surgeons retrospectively indicted shortcystic ducts, acute inflammation, chronic scarring, and ex-cessive bleeding, no obvious problems were encounteredduring the initial surgery in 54% of these cases. For thisreason, use of selective cholangiography in cases only whenthere is a recognized problem, confusion of anatomy, orpossible common duct stones will not affect the incidence orseverity of bile duct injuries. Cholangiography can preventthe most devastating of these injuries—a misidentificationof the common for the cystic duct, with excision of theextrahepatic bile ducts. Additionally, liberal use of cholan-giography should increase the surgeon’s awareness of nor-mal, abnormal, and incomplete studies. It can also improvethe surgeon’s ability to perform cholangiography so thatfewer studies will be aborted.

The injuries that were not recognized during surgerypresented with postoperative symptoms. The average delayin diagnosis was 10 days—even though almost all patientswere seen within 7 days of surgery. Delays resulted frommisinterpretation of the typical signs and symptoms of bileleak or duct obstruction, including protracted complaints ofshoulder and abdominal pain, nausea, vomiting, and eleva-tion of liver function tests. The absence of fever, leukocy-tosis, and ileus did not preclude the presence of bile ductinjury, especially duct obstruction. Noninvasive studies,starting with ultrasonography or HIDA scan, are highly sen-sitive. Endoscopic retrograde cholangiography is usuallydefinitive. It allows for both precise diagnosis and treat-ment, even though several endoscopic retrograde cholan-giograms (ERCP) failed or were misinterpreted in this re-view. Delays in diagnosis were associated with complica-tions that increased damages in 62% of cases.

Long-term morbidity of biliary injury is also related tothe location and extent of injury. Higher ductal injuries(especially Bismuth 4) are associated with an increased riskof postreconstructive failure even after appropriate repair[2]. There is evidence that early recognition and repair of a

bile duct injury by an experienced surgeon leads to im-proved outcome [5]. In this series, 20% of repairs wereperformed immediately, but outcomes were poor anyway.Of nine immediate repairs, eight ultimately failed, requiringreoperation. However, in this selected group of cases, fail-ure of the initial attempt at repair may have predisposed tolitigation. It seems likely that patients who had successfulimmediate repairs were not included in this study becausethey were less likely to sue.

Many surgeons attempted repairs that were unlikely tosucceed due to their own lack of experience with bile ductinjuries. Primary surgeons tried to avoid major duct recon-struction in the hope that repair over a T-tube would sufficeand would be easier to explain than hepaticojejunostomies.Patients with a failed initial attempt at end-to-end repairunderwent an average of two subsequent percutaneous bal-loon dilations and two reoperations prior to successful re-covery. One of these patients still has ongoing problems.Several patients’ injuries were only worsened by inappro-priate attempts at primary repair. For example, a 3-0 silksuture end-to-end repair under tension was performed.

Surgeons with expertise in bile duct repairs had betterresults than primary surgeons (79% versus 27% success) inspite of the fact that they were dealing with more challeng-ing patients who were often in poor condition. When asurgeon diagnoses a bile duct injury, consideration shouldbe given to the resources and circumstances of the surgeonand the patient. In some situations, it is entirely appropriateto place a catheter in the injured duct, drain the area, andtransfer the patient for definitive care to a tertiary center. Ifan injury is suspected postoperatively, thorough evaluationprior to reoperation is advised. Specific identification of thesite of injury can usually be accomplished before reopera-tion. Stabilization of the injury with stents’ placed by ERCPor percutaneous transhepatic radiographic procedures andpercutaneous drainage can be achieved in most cases. If bileduct reconstruction is required, appropriate referral can bemade electively.

Bile duct injuries will always be the worst complicationof cholecystectomy. However, their incidence and severitycan be reduced. Knowledge of how and why they occur,coupled with more liberal use of cholangiography, can helpto prevent debilitating and life-threatening sequelae.

References

1. Chapman WC, Halevy A, Blumgart L, Benjamin I (1995) Post chole-cystectomy bile duct strictures. Arch Surg 130: 597–604

2. McMahon AJ, Fullarton G, Baxter JN, O’Dwyer PJ (1995) Bile ductinjury and bile leakage in laparoscopic cholecystectomy. Br J Surg 82:307–313

3. Meyers WC, Club TS (1991) A prospective analysis of 1518 laparo-scopic cholecystectomies. N Engl J Med 324: 1073–1078

4. Morgenstern L, McGrath MF, Carroll BJ, Paz-Partlow M, Berci G(1995) Continuing hazards of the learning curve in laparoscopic cho-lecystectomy. Am Surg 61: 914–918

5. Pitt HA, Miyamoto T, Parapatis SK, Tompkins RK, Longmire WP(1982) Factors influencing outcome in patients with postoperative bil-iary strictures. Am J Surg 144: 14–21

6. Shea JA, Healey MJ, Berlin JA, Clarke JR, Malet PF, Staroscik RN,Schwartz JS, Williams SV (1996) Mortality and complications associ-ated with laparoscopic cholecystectomy: a metaanalysis. Ann Surg 224:609–620

7. Strasberg SM, Hertl M, Soper NJ (1995) An analysis of the problem ofbiliary injury during laparoscopic cholecystectomy. JACS 180: 101–125

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Discussion

Dr. Rattner: I’ve had the unfortunate experience of repair-ing about 30 bile duct injuries, and subsequently serving asan expert witness for our defense insurer. In reading yourabstract, I was dismayed to find how many of the verdictshad gone in the plaintiff’s favor. In our state, and in Con-necticut, where Ken Kern did a very nice study, it follows atypical medical malpractice situation of a third for the plain-tiff, a third settled, a third for the defendant. I think a factorthat has led to plaintiff’s verdicts, and I must say, there’sonly one case in Massachusetts that’s been litigated and waswon by the defendant surgeon, which is when the surgeonattempts to repair an injury. It’s important to recognize thatif you’ve got a problem and you don’t know how to fix it oryou’re not experienced, you’re best off transferring it tosomebody who does. The first repair is critical, and if itsucceeds, the risk of a lawsuit is much less than if you do aprimary common duct repair and it fails. This may lead tosix months in the hospital and reoperations. My question foryou is whether the presence of videos helped or hurt thesurgeons in their defense.

Dr. Carroll: Four out of five videotapes that were availabledid not help the surgeon. There’s only one case of a duct ofLuschka injury that has an absolutely normal videotape, andI think it will help the surgeon. In general, the videotapes donot help the surgeon to settle a case. In my series, 86% weresettled or had plaintiff verdicts; 14% were defense verdicts.Most of defense verdicts were clip impingements, but therewas one excision of the bile duct where two cuts were madein the bile duct and a piece taken out of the middle that wasdefended in North Dakota.

Dr. Soper:We, too, unfortunately, have had a large expe-rience. The videotapes, similar to this morning, do causeyou to lose your breakfast some of the time. I think some ofthe points you’ve made are key; the critical view of thedissection in the triangle of Calot, or the hepatocystic tri-angle; making sure that in the early postoperative periodanything that deviates from the normal course should besuspected as a common duct injury. How did you arrive atthe denominator of cases in the study that you’ve done? Arethese just ones that were referred to you for management, orones that you were asked to help with the litigation?

Dr. Carroll: They were referred by defense lawyers andplaintiff lawyers and hospital peer reviews for an opinion asto whether the cases met the standard of practice throughoutthe United States. I think your point about patients who areoff the bell-shaped curve in the postoperative period andneed a thorough evaluation is crucial.

Dr. Soper:Do you know what the ultimate denominator inthe United States for this last year was, in terms of numberof malpractice suits specifically in regard to bile duct inju-ries—do we know that number?

Dr. Carroll: No, but the important fact is that in the pub-lished literature there was just a meta-analysis of 98 paperson bile duct injuries since 1990. In 78,000 laparoscopiccholecystectomies, the incidence was approximately 0.3 to0.4 percent. There is probably under-reporting of this injuryand the injury rate is probably higher, probably in the rangeof one in 200 cases, in my opinion.

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News and notices

New Address for the European Association forEndoscopic Surgery (E.A.E.S.)

Effective January 1, 1997, the correspondence, telephone, and fax numbersof the E.A.E.S. office are:

E.A.E.S. Office, c/o Mrs. Ria Palmen

Luchthavenweg 81Unit 1.425657 EA EindhovenThe Netherlandsor: P.O. Box 3355500 AH VeldhovenThe NetherlandsTel: +31 40 2525288Fax: +31 40 2523102

Volunteer Surgeons NeededNorthwestern Nicaragua LaparoscopicSurgery Teaching Program,Leon, Nicaragua

Volunteer surgeons are needed to tutor laparoscopic cholecystectomy forthis non-profit collaboration between the Nicaraguan Ministry of Health,the National Autonomous University of Nicaragua, and Medical TrainingWorldwide. The program consists of tutoring general surgeons who havealready undergone a basic laparoscopic cholecystectomy course. MedicalTraining Worldwide will provide donated equipment and supplies whenneeded.

For further information, please contact:

Medical Training WorldwideRamon Berguer, MD, ChairmanTel: 707-423-5192Fax: 707-423-7578e-mail: [email protected]

Courses at the Washington Institute ofSurgical Endoscopy

We are delighted to offer a variety of regular courses in laparoscopictechniques year round. In addition, special arrangements can be made forindividual tuition in all minimally invasive disciplines. CME credit isavailable and course fees depend on the instruction offered.

For further information, please contact:

Debbie MoserWashington Institute of Surgical Endoscopy2150 Pennsylvania Avenue, N.W.Suite 6-BWashington, DC 20037 USATel: 202-994-8425, or 1-888-8WISEDOCFax: 202-994-0567

Fellowship in Minimally Invasive SurgeryGeorge Washington Medical CenterWashington, DC USA

A one-year fellowship is being offered at the George Washington Univer-sity Medical Center. Interested candidates will be exposed to a broad range

of endosurgical Education and Research Center. Active participation inclinical and basic science research projects is also encouraged.

For further information, please contact:

Debbie MoserTel: 202-994-8425

or, send curriculum vitae to:

Dr. Jonathan M. SackierDirector, Washington Institute of Surgical EndoscopyGeorge Washington University Medical CenterDepartment of Surgery2150 Pennsylvania Avenue, N.W.6B-417Washington, DC 20037, USA

Essentials of Laparoscopic SurgerySurgical Skills UnitUniversity of DundeeScotland, UK

Under the direction of Sir A. Cuschieri the Surgical Skills Unit is offeringa three-day practical course designed for surgeons who wish to undertakethe procedures such as laparoscopic cholecystectomy. This intensely prac-tical program develops the necessary operating skills, emphasizes safepractice, and highlights the common pitfalls and difficulties encounteredwhen starting out. Each workshop has a maximum of 18 participants whowill learn both camera and instrument-manipulation skills in a purpose-built skills laboratory. During the course there is a live demonstration of alaparoscopic cholecystectomy. The unit has a large library of operativevideos edited by Sir Cuschieri, and the latest books on endoscopic surgeryare on display in our Resource area. Course fee including lunch and coursematerials is $860.

For further details and a brochure please contact:

Julie Struthers, Unit Co-ordinatorSurgical Skills UnitNinewells Hospital and Medical SchoolDundee DD1 9SYTel: +44 382 645857Fax: +44 382 646042

Advanced Endoscopic SkillsSurgical Skills UnitUniversity of DundeeScotland, UK

Each month Sir A. Cuschieri Surgical Skills Unit offers a 41⁄2 day coursein Advanced Endoscopic Skills. The course is intensely practical with‘‘hands on’’ experience on a range of simulated models. The program isdesigned for experienced endoscopic surgeons and covers advanced dis-section techniques, extracorporeal knotting techniques, needle control, su-turing, internal tying technique, stapling, and anastomotic technique. Indi-vidual workstations and a maximum course number of 10 participantsallows for personal tuition. The unit offers an extensive collection of sur-gical videos and the latest books and publications on endoscopic surgery.In addition, participating surgeons will have the opportunity to see liveadvanced laparoscopic and/or thoracoscopic procedures conducted by SirCuschieri and his team. The course is endorsed by SAGES. Course feeincluding lunch and course materials is $1850.

© Springer-Verlag New York Inc. 1998Surg Endosc (1998) 12: 383–385

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For further details and a brochure please contact:

Julie Struthers, Unit Co-ordinatorSurgical Skills UnitNinewells Hospital and Medical SchoolDundee DD1 9SYTel: +44 382 645857Fax: +44 382 646042

The Practical Aspects of Laparoscopic FundoplicationSurgical Skills UnitUniversity of DundeeScotland, UK

A three-day course, led by Sir A. Cuschieri, designed for experienced lapa-roscopists wishing to include fundoplication in their practice. The course cov-ers the technical details of total and partial fundoplication using small groupformat and personal tuition on detailed simulated models. There will be anopportunity to observe one of these procedures live during the course. Maxi-mum course number is six. Course fee including lunch is $1850.

For further details and a brochure please contact:

Julie Struthers, Unit Co-ordinatorSurgical Skills UnitNinewells Hospital and Medical SchoolDundee DD1 9SYTel: +44 382 645857Fax: +44 382 646042

Courses at the Royal Adelaide Centre forEndoscopic Surgery

Basic and Advanced Laparoscopic Skills Courses are conducted by theRoyal Adelaide Centre for Endoscopic Surgery on a regular basis. Thecourses are limited to six places to maximize skill development and tuition.Basic courses are conducted over two days for trainees and surgeons seek-ing an introduction to laparoscopic cholecystectomy. Animal viscera insimulators is used to develop practical skills. Advanced courses are con-ducted over four days for surgeons already experienced in laparoscopiccholecystectomy who wish to undertake more advanced procedures. Awide range of procedures are included, although practical sessions can betailored to one or two procedures at the participants request. Practical skillsare developed using training simulators and anaesthetised pigs.

Course fees: $A300 ($US225) for the basic course and $A1,600($US1,200) for the advanced course.

For further details and brochure, please contact:

Dr. D. I. Watson or Professor G. G. JamiesonThe Royal Adelaide Centre for Endoscopic SurgeryDepartment of SurgeryRoyal Adelaide HospitalAdelaide SA 5000 AustraliaTel: +61 8 224 5516Fax: +61 8 232 3471

Advanced Laparoscopic Suturing and SurgicalSkills Courses

MOET InstituteSan Francisco, CA, USA

Courses are offered year-round by individual arrangement. The MOETInstitute is accredited by the Accreditation Council for Continuing MedicalEducation (ACCME) to provide continuing medical education for physi-cians and designates these CME activities for 20–40 credit hours in Cat-egory 1 of the Physician’s Recognition Award of the American MedicalAssociation. These programs are also endorsed by the Society of Gastro-intestinal Endoscopic Surgeons (SAGES).

For further information, please contact:Wanda Toy, Program AdministratorMicrosurgery & Operative Endoscopy Training (MOET) Institute153 States StreetSan Francisco, CA 94114, USATel: (415) 626-3400Fax: (415) 626-3444

Cours Europeen de Chirurgie Laparoscopique(European Course on Laparoscopic Surgery)under the auspices of E.A.E.S.University Hospital Saint-Pierre (U.L.B.)

May 12–May 15, 1998November 17–November 20, 1998Brussels, Belgium

Course Director: G.B. Cadiere, MDUniversiteLibre de Bruxelles (U.L.B.)Department of G.I. SurgeryUniversity Hospital Saint-Pierre

The course will include live demonstrations and interactive dialogue withthe operating surgeons and a video forum with discussions of videotapes,technical details, and pitfalls.

Topics include functional gastric surgery (Nissen-Toupet-gastroplasty),colon (colectomy-rectopexy), hernia (trans-/preperitoneal approach, bal-loon), retroperitoneoscopy, splenectomy, needle surgery, biliary surgery,and new technologies.

Surgeons include J. Bruyns, G.B. Cadiere, J. Himpens, J. Leroy, and M.Vertruyen.

The official language for the May course is French with simultaneoustranslation provided into English. The official language for the Novembercourse is English with no simultaneous translation.

Internet site: http://www.LAP-SURGERY.com

For further information, contact:

Scientific InformationMrs. Solange IzizawC.H.U. Saint-PierreService de Chirurgie DigestiveRue Haute 322B-1000 Bruxelles, Belgiumemail: [email protected]

or

Administrative SecretariatConference Services S.A.Avenue de l’Observatoire 3, bte 17B-1180 Bruxelles, Belgiumemail: [email protected]

6th World Congress of Endoscopic Surgery ‘‘Roma 98’’6th International Congress of European Associationfor Endoscopic Surgery

May 31–June 6, 1998Rome, Italy

This World Congress is being organized with the cooperation of IFSES.The program will include: the latest, original high quality research; sym-posia; plenary lectures; abstract presentations (video, oral, and posters);EAES and SAGES postgraduate courses, OMED postgraduate course ontherapeutic endoscopy; working team reports; educational center and learn-ing corner; meeting of the International Society of Nurses and Associates;original and non original scientific reports; and a world expo of newtechnology in surgery.

For further information, please contact:

Congress Secretariat: Studio EGAViale Tiziano, 1900196 Rome, ItalyTel: +39 6 322-1806Fax: +39 6 324-0143email: [email protected]://www.ega.it/worldendo98

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Second International Congress of Thorax SurgeryJune 24–27, 1998Palazzo della Cultura e del Congressi, Bologna, Italy

For further information, please contact the Scientific Secretariat:

Dott. A. BiniDepartment of Thorax SurgerySaint Orsola University HospitalVia Massarenti, 940138 Bologna, ItalyTel: (+3951) 344068-6363287Fax: (+3951) 305092

International Course in LaparoscopicColorectal Surgery

September 2–4, 1998Trondheim, Norway

Course Directors: R. Mårvik, MD, R. Bergamaschi, MDHost Chairman: H.E. Myrvold, MDGuest Faculty: S.D. Wexner, MD

For further information, please contact:

National Center for Advanced Laparoscopic SurgeryTrondheim University and Regional Hospital7006 Trondheim, NorwayTel: +47-73-999888Fax: +47-73-999889

Tenth International Conference of the Society for Mini-mally Invasive Therapy

September 3–5, 1998London, England

Host Chairman: Mr. J. Wickham

For further information, please contact:

The Society for Minimally Invasive Therapy2nd Floor, New Guy’s HouseGuy’s HospitalSt. Thomas StreetLondon, SE1 9RT, EnglandTel: +44 (0)171 955 4478Fax: +44 (0)171 955 4477email: [email protected]

Current Trends in Colon and Rectal SurgerySeptember 24–26, 1998Naples, Italy

Current Trends in Colon and Rectal Surgery, sponsored by the Universityof Naples, George Washington University, and the Cleveland Clinic, will

be held September 24–26, 1998, at the Sorento Palace Conference Centerin Naples, Italy.

For further information, please contact:

Office of Continuing Medical EducationGeorge Washington University Medical Center2300 K Street, NWWashington, DC 20037, USATel: (202) 994-4285

or

Dottore Vincenzo LandolfiSecond University Universita BDI NapoliCattedra di Chirurgia dell’ Apparoato DiGenrentePrimary Policlinico—Piazza Miraglia 380138 Napoli, ItalyTel: 011-39-81-566-5279Fax: 011-39-81-459-137e-mail: comvplan@syren

Third Congress of the International Federation for theSurgery of Obesity (IFSO)

September 3–5, 1998Holiday Inn Crowne Plaza, Bruges, Belgium(12th International Symposium on Obesity Surgery)

International papers and symposia covering the field of laparoscopic andopen bariatric surgery.

For further information, please contact:

Third Congress of the IFSO SecretariatPost Office Box 80B-8310 BrugesSint Kruix, Belgium

or

J.W.M. Greve, M.D.Fax +31-43-387-5473email: [email protected]

or

George S.M. Cowan, Jr., M.D.Professor of SurgeryUniversity of Tennessee956 Court AvenueSuite A 212Memphis, TN 38163, USATel: (901) 448-6781Fax: (901) 448-4688email: [email protected]

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Laparoscopic liver surgery

A report on 28 patients

J. Marks,1 J. Mouiel,2 N. Katkhouda,2 J. Gugenheim,2 P. Fabiani2

1 Department of Surgery, Allegheny University of the Health Sciences, Hahnemann Division, Broad and Vine, M. S. 413,Philadelphia, PA 19102-1192, USA2 Department of Surgery, Hopital Saint-Roch, University of Nice Sophia-Antipolis, B.P. 319-06006-Nice Cedex 1, France

Received: 10 May 1996/Accepted: 26 July 1996

AbstractBackground:An effort was made to evaluate the indica-tions, safety, and therapeutic efficacy of laparoscopic liversurgery.Methods:Between 1989 and 1996, 28 patients, 23 to 88years old were operated upon laparoscopically. Pathologyconsisted of simple cyst (ten), polycystic liver disease(seven), hydatid cyst (three, two of them calcified), abscess(one), focal nodular hyperplasia (six), and metastatic breastcancer (one).Results:Operations included 17 fenestrations, three pericys-tectomies, and eight resections (two lateral lobes). Opera-tive time was 45 to 525 min with only four cases longer than4 h. There was a 21% morbidity rate. There were no mor-talities. Follow-up was 1–67 months with one asymptomaticrecurrence.Conclusions:Laparoscopic hepatic surgery can be per-formed safely with good results by surgeons with hepaticand laparoscopic experience when careful selection criteriaare followed. We advocate the ‘‘four-hands technique’’ forsimultaneous dissection and control of bleeding and bileducts during resections.

Key words: Laparoscopic surgery — Hepatic surgery —Liver — Four-hands technique

Following the introduction of laparoscopic cholecystectomyin 1987, the laparoscopic approach has been applied to thefull spectrum of abdominal procedures [6–8, 11, 15, 16].Despite this proliferation, the liver has been virtually ig-nored and, perhaps, with good reason. To safely performliver surgery laparoscopically, the surgeon must be both anaccomplished laparoscopist and hepatic surgeon. Few sur-

geons, however, are as comfortable with open hepatic sur-gery as they are with the gallbladder, hernia, appendix, orstomach. Moreover, the equipment required is expensiveand probably best purchased jointly with another depart-ment, perhaps urology or gynecology, to defray the cost.Furthermore, only a limited number of lesions, dependingupon their location and etiology, can be approached in thismanner. However, having satisfied these criteria, the lapa-roscope can certainly be applied to the liver.

We report here our experience with laparoscopic liversurgery in a select group of 28 patients from an activepractice of hepatic surgery. The ‘‘four-hands technique’’ forhepatic resection is described.

Methods

Between 1989 and 1995, 28 patients, 20 of them women, underwent lap-aroscopic hepatic surgery at Saint Roch Hospital, University of NiceSophia-Antipolis. The ages of the patients ranged from 23 to 88 years(mean of 54 years). There were lesions in the right lobe in four cases, theleft lobe in 17 cases, and bilateral in the other seven cases. The preopera-tive diagnosis included symptomatic solitary hepatic cyst (ten), symptom-atic polycystic liver disease (PCLD) (seven), hydatid cyst (two) (one cal-cified), focal nodular hyperplasia (FNH) (three), adenoma (three), abscess(one), metastatic breast cancer (one), and calcified gallbaldder (one). Thesize of the lesions ranged from 2.5 to 22 cm with a mean of 8.4 cm.

Presenting complaints included: pain (14), compressive symptoms(seven), abnormal x-rays (five), and sepsis (two). Preoperative radio-graphic evaluation varied considerably depending upon the diagnosis andproposed procedure. Evaluation included CAT scan (18), ultrasound (15),MRI (four), arteriography (three), and/or EGD (5). Nine patients had threeor more studies.

Technique

The procedures were performed with the patient under general anesthesiawith oro- or nasogastric decompression and a pneumoperitoneum of 12–14mmHg. The patients were in the ‘‘French’’ position, a modified lithotomywith minimal flexion of the hips, and the primary surgeon positionedbetween the legs. The first assistant or second surgeon was on the patient’sleft side. The scrub nurse was between them. For fenestrations, we used afour-trocar configuration. A 10-mm port at the umbilicus housed the 0°laparoscope. A 5-mm trocar was placed just below the xiphoid process toCorrespondence to:J. Marks

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the right or the left of the falciform ligament, depending on the location ofthe cyst. This port was used to expose the liver, often using an irrigation-aspiration probe. Two other 5-mm or 10-mm ports, in the right and leftflank, allowed the surgeon to puncture the cyst dome, aspirate its contents,and excise the cyst wall in a careful sequential fashion to facilitate hemo-stasis.

For more extensive procedures, a strong light source (300-W xenon)and high-quality 0° and 30° scopes are required. To perform resectionssafely with a minimum of wasted motion, we advocate the ‘‘four-handstechnique.’’ This uses four to six trocars (Fig. 1) and allows for the primarysurgeon to expose and dissect the liver while surgeon 2 obtains control andtransects the blood vessels and bile ducts. The procedure entails the samecomponents as in open hepatic surgery. First, the patient is explored, bothvisually and ultrasonographically. Mobilization of the liver and hilar dis-section are performed as necessary to obtain vascular control. Division andligation of the round ligament followed by freeing of the falciform and theright or left triangular ligaments allow access to perform thorough explo-ration, resection, and hemostasis. Should bleeding become a problem, thiscan be controlled by directly clamping the liver or performing a Pringlemaneuver. Dissection is begun by scoring Glisson’s capsule with the elec-trocautery or Nd:Yag laser. Parenchymal dissection is performed using theultrasonic dissector (Tetrad Corporation) or the laparoscopic equivalent ofthe finger fracture technique, ‘‘kellyclasia’’: using a dissecting forcep tograsp the tissue and gently compress it, leaving only the bile ducts andvessels to be ligated with clips or ties and transected. Following resection,the mass is placed in an impermeable specimen bag for removal. Cholan-giography is very useful to detect possible bile leaks. The raw surface ofthe liver is then inspected, coagulated by Nd:Yag laser, and covered withfibrin glue (Tissucol, Immuno, Vienna, Austria). The specimen is extractedeither by partial morceillation, dilatation at the umbilicus, enlarging an-other port site, or by a small McBurney or subcostal incision.

Results

The procedures performed with the associated pathology areshown in Tables 1, 2, and 3. Ten patients also underwentcholecystectomy with intraoperative cholangiography.Mean operative time was 179 min (range 45–525 min).Only four operations lasted longer than 4 h: the lateral lo-bectomy, the sterilization and evacuation of a hydatid cyst,

and two procedures with patients undergoing extensive fen-estrations for polycystic liver disease.

Three of the cases were converted to open procedures(11%). Two of these were done immediately following ex-ploration: one because the mass was too close to the inferiorvena cava on ultrasound and the other because the giant cyststretched too far posteriorly to allow for safe vascular con-trol. In the third patient with FNH, the dissection was wellunderway when it was determined that the mass extendedtoo close to the vascular pedicle to use the Ultrasonic CUSA(Pfizer Howmedica, Boulder, CO, USA) safely. Intraopera-tive complications consisted solely of two cases of hemor-rhage in patients with PCLD requiring a 5-cm minilapa-rotomy to oversew the bleeding point. These two patientsand one woman with FNH, who autodonated her bloodbefore a wedge resection, were each transfused two unitsand represent the only patients receiving transfusions(11%). Morbidity consisted of a urinary tract infection,phlebitis, and in the PCLD group, two cases of ascites (onetreated immediately and one requiring drainage), one intra-abdominal infection treated with p.o. antibiotics, and a de-layed abscess requiring a reoperation 5 months later in apatient whose cyst had been sclerosed preoperatively withalcohol. There was no mortality.

Hospital stay averaged 7.7 days with a range of 1–44days. Follow-up ranged from 1 to 67 months. There was onerecurrence (4%) found on routine ultrasound 5 months post-operatively in an asymptomatic patient with PCLD.

Discussion

The indications and preparation for laparoscopic liver sur-gery remain the same as in open hepatic surgery. Un-changed, too, are the component parts of the procedure:exploration, mobilization and vascular control, parenchym-nal dissection, hemostasis, and specimen extraction. Visu-alization is excellent with the laparoscope, but the additionof laparoscopic ultrasound has been shown to alter intraop-erative plans in up to 66% of cases when compared tolaparoscopic exploration alone [2]. While not necessary forall fenestrations, we strongly advocate its use when con-

Fig. 1. Trochar position: four-hands technique.

Table 1. Proceduresa

Fenestrations 16/17b

Pericystectomy 2/2Cyst sterilization and partial cystectomy 1/1Wedge resection 5/6Left lateral lobectomy 1/2

a Numerator represents successful laparoscopically completed cases.b Two patients required minilaparotomy for control of bleeding.

Table 2. Pathology

Solitary hepatic cyst 10Polycystic liver disease 7Hydatid cyst 3

Active 1Calcified 2

FNH 6Abscess 1Metastatic breast cancer 1

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templating more extensive procedures. Adequate mobiliza-tion and hilar dissection are essential to minimize the risksof bleeding and air embolus. We introduced here the con-cept of the ‘‘four-hands technique.’’ This is a major im-provement, and we strongly advocate this for laparoscopicresections. This surgery is technically challenging and timeconsuming. By having surgeon 1 dissect while surgeon 2keeps the visual field clear with the irrigation and aspiration,the procedure can proceed in a step-wise and orderly fash-ion. This allows for surgeon 2 to clamp or clip vessels priorto surgeon 1 cutting them, a very important point in lapa-roscopic hepatic surgery. Pneumoperitoneum coupled withthe partial transection of a large uncontrolled hepatic intra-parenchymal vessel could not only result in hemorrhage butalso in a potentially large CO2 embolus. While we have notexperienced this complication, we believe it is due to acontinual recognition of this as a potential disaster. In fact,two of our three conversions were due to the proximity ofmajor vascular structures. No problems occurred with bilo-mas postoperatively. The high-quality optics allow foreasier visualization of uncontrolled bile ducts. In addition,one must have a willingness to proceed with a cholangio-gram to clarify the anatomy or identify leaks if questionsexist. By combining careful dissection and vascular controlwith the use of laser cautery and Tissucol to the cut surfaceof the liver, problems with postoperative bleeding or hema-tomas were entirely avoided. We attribute our low incidenceof intraoperative complications and our absence of mortalitynot only to great technical care but to a low threshold toconvert to an open procedure. As in all laparoscopic proce-dures, this does not represent a failure but rather good sur-gical judgment.

Our experience, as well as that of other authors [5, 9, 10,14], indicates that laparoscopic hepatic surgery, while tech-nically difficult, can be performed safely with good resultswith careful patient selection. Attention to the etiology ofthe lesion and its location is essential. Ideal candidates havea large solitary cyst or a symptomatic benign mass locatedsuperficially, laterally, or far enough from the pedicle toallow direct clamping of the liver or access to the hilum toperform a Pringle maneuver should bleeding occur. Thisexplains the preponderance of left lobe lesions in our series.Contraindications to this technique include patients withcirrhosis, hepatocellular carcinoma, or posterior or centrallylocated lesions. While we have utilized this approach forsolitary small metastatic disease, hydatid disease, hepaticabscess, and PCLD, these should be viewed with a greatdeal of circumspection. Problems exist to varying degrees

should any of these lesions be spilled. Port site recurrenceshave not yet been reported for hepatic cancers, but thisremains a concern when using laparoscopy in any patientwith cancer [17]. This is of special concern when consid-ering pairing this approach with cryoablation [4]. With echi-nococcal cysts, the risk of spillage is also obvious, thoughless problematic with calcified cysts. Techniques and in-struments for minimizing this problem are described [1, 3,12, 13, 15], but one must be highly selective with this sur-gery. If one does use a laparoscopic approach for hydatiddisease, we recommend a cholangiogram to rule out a con-nection with the biliary system. While fenestration of poly-cystic liver disease has been described by others both byopen and laparoscopic approaches, we have found this dis-ease particularly bothersome. Transcystic fenestration ofdeeper cysts makes the control of bleeding very difficult.Suddenly one is working very centrally. Indeed, our onlytwo operative complications were venous bleeding fromcentral cysts in patients with polycystic liver disease requir-ing a 5-cm minilaparotomy for control. Furthermore, two-thirds of our morbidities occurred in this group.

Many obstacles exist to laparoscopic hepatic surgery.The required equipment is expensive. The surgery is oftendifficult. However, laparoscopic liver surgery is a viableoption when careful patient selection is performed. In thehands of a skilled hepatic and laparoscopic surgeon who isequipped with the proper tools, these procedures are safe,effective, and reproducible.

References1. Alper A, Emre A, Hazar H, Ozden I, Bilge O, Acarli K, Ariogul O

(1995) Laparoscopic surgery of hepatic hydatid disease: initial resultsand early follow-up of 16 patients. World J Surg 19(5): 725–728

2. Barbot D, Marks J, Feld R, Liu J, Rosato F (1995) Improved stagingof liver tumors using laparoscopic intraoperative ultrasound. J SurgOncol (accepted for publication)

3. Cappuccino H, Campanile F, Knecht J (1994) Laparoscopy-guideddrainage of hepatic abscess. Surg Laparosc Endosc 4(3): 234–237

4. Cuschieri A, Crosthwaite G, Shimi S, Pietrabissa A, Joypaul V, Tair I,Naziri W (1995) Hepatic cryotherapy for liver tumors: developmentand clinical evaluation of a high-efficiency insulated multineedleprobe system for open and laparoscopic use. Surg Endosc 9(5): 483–489

5. Ferzli G, David A, Kiel T (1995) Laparoscopic resection of a largehepatic tumor. Surg Endosc 9(6): 733–735

6. Fitzgibbons RJ Jr, Camps J, Nguyen N, Litke BS, Annibali R, SalernoGM (1995) Laparoscopic inguinal herniorrhaphy: results of a multi-center trial. Ann Surg 21(1): 3–13

7. Frazee RC, Roberts JW, Symmonds RE, et al (1994) A prospectiverandomized trial comparing open versus laparoscopic appendectomy.Ann Surg 219:725–731

Table 3. Procedures performed for associated pathology

MaxSymptomatichepatic cyst

Polycycticliverdisease Abscess Calcified

Hydatiddisease FNH

Metastaticbreast CA Total

Fenestration 10 6/7a 16/17a

Sterilization, evacuation,and partial cystectomy 1 1

Pericystectomy 2 2Wedge resection 1 3/4a 1 5/6a

Left lateral lobectomy 1/2a 1/2a

Total 10 7 1 1 2 6 1 28

a Numerator completed laparoscopically.

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8. Katkhouda N, Mouiel J (1991) A new technique of surgical treatmentof chronic duodenal ulcer without laparoscopy by videocoelioscopy.Am J Surg 161: 361–364

9. Libutti SK, Starker PM (1994) Laparoscopic resection of a nonpara-sitic liver cyst. Surg Endosc 8(9): 1105–1107

10. Morino M, DeGiuli M, Festa V, Garrone C (1994) Laparoscopic man-agement of symptomatic nonparasitic cysts of the liver: Indicationsand results. Ann Surg 219(2): 157–164

11. Phillips EH, Franklin M, Carroll BJ, Fallas MJ, Ramos R, Rosenthal D(1992) Laparoscopic colectomy. Ann Surg 216: 703–707

12. Robles PJ, Lara JG, Lancaster B (1994) Drainage of hepatic amebicabscess successfully treated by laparoscopy. J Laparoendosc Surg4(6): 451–454

13. Rogiers X, Bloechle C, Broelsch CE (1995) Safe decompression of

hepatic hydatid cyst with a laparoscopic surgiport. Br J Surg 82(8):1111

14. Schwartz DS, Gwertzman G, Kaleya RN, Gliedman ML (1994) Lap-aroscopic unroofing of multiple benign liver cysts with intraperitonealdrainage: a case report. J Laparoendosc Surg 4(2): 157–160

15. Soper NHJ, Stockman PT, Dunnegan DL, Ashely SW (1992) Lapa-roscopic cholecystectomy—the new gold standard. Arch Surg 127:917–923

16. Weerts JM, Dallemagne B, Hamoir E, Demarche M, Markiewicz S,Jehaes C, Lombard R, Demoulin JL, Etienne M, Ferron PE, FontaineF, Gillard V, Delforge M (1993) Laparoscopic Nissen fundoplication:detailed analysis of 132 patients. Surg Laparosc Endosc 3: 359–364

17. Wexner SD, Cohen SM (1995) Port site metastases after laparoscopiccolorectal surgery for cure of malignancy. Br J Surg 82: 295–298

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Bile duct injury after laparoscopic cholecystectomy

The United States experience

B. V. MacFadyen, Jr.,1 R. Vecchio,2 A. E. Ricardo,1 C. R. Mathis1

1 Department of Surgery, The University of Texas Medical School, 6431 Fannin, #4292, Houston, Texas 77030, USA2 Department of Surgery, University of Catania, Via Carnazza n. 2, 95030 Tremestieri Etneo, Italy

Received: 24 September 1996/Accepted: 28 July 1997

AbstractBackground:Forty series reporting experience with laparo-scopic cholecystectomy in the United States from 1989 to1995 were reviewed. A total of 114,005 cases were ana-lyzed and 561 major bile duct injuries (0.50%) and 401 bileleaks from the cystic duct or liver bed (0.38%) were re-corded. Intraoperative cholangiography (IOC) was at-tempted in 41.5% of the laparoscopic cholecystectomiesand was successful in 82.7%. In major bile duct injuries, thecommon bile duct/common hepatic duct were the most fre-quently injured (61.1%) and only 1.4% of the patients hadcomplete transection.Methods:When reported, most of the bile duct injuries weremanaged surgically with a biliary-enteric anastomosis(41.8%) or via laparotomy and t-tube or stent placement(27.5%). The long-term success rate could not be deter-mined because of the small number of series reporting thisinformation. The management for bile leaks usually con-sisted of a drainage procedure (55.3%) performed endo-scopically, percutaneously, or operatively.Results:The morbidity for laparoscopic cholecystectomy,excluding bile duct injuries or leaks, was 5.4% and theoverall mortality was 0.06%. It was also noted that theconversion rate to an open procedure was 2.16%.Conclusions:It is concluded based on this review of lapa-roscopic cholecystectomies that the morbidity and mortalityrates are similar to open surgery. In addition, the rate of bileduct injuries and leaks is higher than in open cholecystec-tomy. Furthermore, bile duct injuries can be minimized bylateral retraction of the gallbladder neck and careful dissec-tion of Calot’s triangle, the cystic duct–gallbladder junction,and the cystic duct–common bile duct junction.

Key words: Bile duct injury — Bile leak — Laparoscopiccholecystectomy

Approximately 500,000–600,000 cholecystectomies areperformed each year in the United States [48], accountingfor almost 25% of a general surgery practice. Since theclinical introduction of laparoscopic cholecystectomy (LC)in 1989, it has become the technique of choice for gallblad-der removal. Initially, the utilization of this technique waspushed by the media, by patient demand, by industry, andby physician competition. Rapid adoption into clinical sur-gical practice, however, preceded studies on its effective-ness and safety. Early series of LC reported an incidence ofmajor complications ranging from 1.0 to 8.0% [6, 38, 41,52, 66, 68]. These problems included hemorrhage, woundinfection, trocar and Veress needle injuries, bile duct injuryand leakage, and organ system failure.

Among the major complications of LC, bile duct inju-ries are the most difficult challenge because they can resultin considerable patient disability. In early published series,the rate of laparoscopic-related bile duct injuries and leakshas been reported to range from 0.0 to 2.0% [41, 49, 52, 64,68, 74], which is higher than the 0.1% to 0.25% for opencholecystectomy [2, 27, 44]. The reported number of iatro-genic bile duct injuries in various series has often excludedthe denominator, which is the total number of laparoscopiccholecystectomies performed. This study was undertaken todetermine the actual incidence of bile duct injuries and bileleaks.

Methodology

A Medline review of large series of laparoscopic cholecystectomies fromthe U.S. literature from January 1991 to December 1995 was undertaken.Within this evaluation, five series came from preoperative studies and 11papers were reported from multi-institutional reviews. There were a total of114,005 cases and the following data were assessed: the incidence of bileduct injuries and bile leaks, the type and location of these lesions, the timeof recognition, the results of early and delayed bile duct repair procedures,their therapeutic management and results, and possible etiologic factorsresponsible for these problems. In addition, the data were evaluated on thenumber of conversions to an open procedure, the utilization of intraopera-tive cholangiography (IOC), morbidity, and mortality.Correspondence to:B. V. MacFadyen, Jr.

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The biliary complications were categorized by differentiating bile ductinjuries from bile leaks. Bile duct injuries (BDI) were further subdividedinto direct laceration (partial or complete transection of the bile duct), andtheir location as to whether they involved the common bile duct (CBD), thecommon hepatic duct, the right hepatic duct, or one of the intrahepaticbranches of the liver. Cystic duct avulsion and necrosis were includedbecause they also produced an associated common bile duct injury. Bileleaks were classified as originating from the cystic duct, the accessory ductbetween the gallbladder and liver (Duct of Luschka), the gallbladder fossa,or from liver biopsy sites.

Results

Table 1 records the series of 114,005 laparoscopic chole-cystectomies (LC) that were analyzed. The indications forLC included acute and chronic cholecystitis and cholelithi-asis, acalculous cholecystitis, motility disorders of the gall-bladder, and gallstone pancreatitis. The most commonpreoperative diagnostic procedure prior to LC was ultraso-nography; however, endoscopic retrograde cholangiopan-

creatography with endoscopic sphincterotomy (ERCP-ES)and/or percutaneous transhepatic cholangiography (PTC)was obtained when choledocholithiasis was suspected. Inonly 20,262 patients was the underlying pathology stated,and it was only possible in this group to determine theincidence of acute cholecystitis (2,346 patients—11.6%) [1,5, 6, 11–13, 18, 21–23, 25, 29–31, 33, 36, 38, 43, 45, 49, 53,59–62, 65, 66, 68, 71]. The rate of conversion to an opencholecystectomy occurred in 2,201 of 102,085 patients(2.16%) [1, 4–6, 8, 11–13, 16, 18, 20–23, 25, 29–31, 36, 38,42, 43, 45, 47, 49, 53, 59–62, 65–68, 71, 72] and acuteinflammation accounted for 44.7% of these conversions fol-lowed by fibrosis, adhesions, unclear anatomy, commonbile duct exploration, and bile duct injuries.

A total of 561 bile duct injuries were reported in112,532 cases (0.5%) [1, 4–6, 8, 12, 13, 16, 18–23, 25,29–33, 36, 38, 42, 43, 45, 47, 49, 53, 59–62, 65–68, 71, 72](Table 2). It should be noted that if a study did not mentionbile duct injury, it was not assumed to be zero and thesecases were excluded from the calculation. Table 3 recordsthe site of bile duct injury in the 561 patients [1, 4–6, 8, 12,13, 16, 18–23, 25, 29–33, 36, 38, 42, 43, 45, 47, 49, 53,59–62, 65–68, 71, 72]. The common bile duct and the com-mon hepatic duct were injured in 343 of the 561 cases(61.1%), followed by cystic duct injury, which occurred in101 of 561 cases (18%) and an aberrant duct in 48 of the561 cases (8.6%). Complete transection of the common bileoccurred in eight of 561 cases (1.4%) and injury to the leftor right hepatic ducts was described in 10 cases (1.8%). Thisis contradictory to previous reports of bile duct injury. How-ever, in most series reviewed in this paper, although thelocation of the injury was documented, the type of CBDinjury was not specified in the majority of cases, so theremay be more complete transections than are noted in thisreport. However, when the type of injury was recorded, itwas most commonly a small hole or laceration, cystic ductavulsion from the CBD, or improperly applied metal clips.

The corrective therapy reported in 561 bile duct injuriesis listed in Table 4 [1, 4–6, 8, 12, 13, 16, 18–23, 25, 29–33,36, 38, 42, 43, 45, 47, 49, 53, 59–62, 65–68, 71, 72]. Thespecific management of these injuries was reported in only182 of those cases (32.4%), and the remaining cases werenot sufficiently specified to analyze (379). Of the 182 casesspecifying treatment of a bile duct injury, the vast majoritywere treated surgically (97.3%) and most of those wereeither a biliary-enteric anastomosis (76), choledochoduode-nostomy (eight), or end-to-end anastomosis (eight). The re-maining surgical repairs consisted of T-tube or stent place-ment (50), primary suture repair without drainage (28), orsimply removal of a misapplied clip (seven). In only fivecases was nonsurgical therapy reported which consisted ofeither endoscopic or percutaneous stent placement.

In only 66 of the 561 (11.8%) cases was the time of

Table 1. Laparoscopic cholecystectomy series

Referenceno.

No.patients

Mean age—years(range) Male/female

68a,b 1,518 47 (8–98) 0.3466 500 46 (17–86) NS38a 1,983 (13–98) NS6 800 NSc NS8 418 NS NS

23 350 NS NS53 283 46.1 0.2636 300 (12–85) 0.1945 82 49 (21–85) 0.285 375 NS NS

33 50 51 (20–72) 0.5672 381 45 ± 15 NS13 90 48.6 (20–77) 0.2330a 304 50 (14–83) 0.2261 152 43.2 (17–83) 0.2960 60 31 (22–80) 0.2918 622 48 (17–97) 0.3425a 261 49 (17–94) 0.3365 618 47 (15–82) 0.2867 280 NS NS29a 300 47 (18–80) 0.6462 271 50.8 (15–91) 0.3116 250 49 (15–97) 0.3722 111 43.3 (24–72) 0.2921 100 43.6 (16–80) NS19a 9,597 NS NS12b 514 47.2 (15–93) 0.2431 100 46 (15–84) NS42a 762 49.9 (14–96) 0.2111b 650 NS NS20a 77,604 NS NS49a 4,640 NS 0.3471 1,107 56 (10–94) 0.4932 1,000 NS NS47b 2,427 NS NS1a 2,671 NS NS

43a,b 950 48.8 (13–97) 0.204 201 44.2 0.21

59 500 45.5 (17–87) 0.2170 823 NS NSTotal 114,005 47.0

a Multicenter.b Prospective study.c NS: not specified.

Table 2. Incidence of bile duct injury and bile leak after laparoscopiccholecystectomy

Bile ductinjury

Bileleak

561/112,532 cases(0.50%)

401/105,438 cases(0.38%)

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recognition of injury reported [1, 5, 8, 12, 18, 29, 30, 32, 33,38, 43, 47, 49, 53, 59–61, 65, 68]. Of these cases, 44(66.6%) were recognized at the time of LC and the remain-der were diagnosed postoperatively. The difference in theapproach to management of bile duct injuries discoveredimmediately or delayed is evident in Table 5 [1, 5, 8, 12, 18,29, 30, 32, 33, 38, 43, 47, 49, 53, 59–61, 65, 68]. It isinteresting to note that the majority of cases diagnosed im-mediately underwent primary repair of the injury with orwithout drainage (59%), whereas those whose injury wasdiagnosed postoperatively usually had a biliary-entericanastomosis (72.7%).

It is difficult to analyze a success rate for any of thesetreatments for bile duct injury since the majority of reportsdid not specify immediate, short-term, or long-term successfrom the therapy. However, some trends can be noted. Ofthe 182 cases that specified treatment of a bile duct injury,only nine early failures were reported (4.9%). All nine re-ported failures had undergone surgical management of theirinjury, although it should be noted that 97.3% of the totalcases had undergone a surgical procedure. However, themethod by which the failures were treated varied. Two-thirds of the failed cases did not undergo repeat operationand were successfully managed endoscopically or percuta-neously. One-third of the failures did require another lapa-rotomy with a successful immediate outcome. The cause ofthe failure in seven of the nine cases was most often diag-nosed as postoperative stricture formation (71.4%) and sec-ondarily as bile leakage (28.6%) [1, 6, 29, 32, 47, 49, 65].

The compilation of series in this review reported 401bile leaks in 105,438 laparoscopic cholecystectomies(0.38%) [1, 4–6, 11–13, 16, 18, 20–23, 25, 29–31, 33, 36,38, 42, 43, 53, 59–62, 65–68, 70–72] (Table 2). Again, itshould be noted that if no mention was made of a bile leak,it was not assumed to be zero and these cases were excludedfrom the calculation. Of the 401 bile leaks recorded, a spe-cific location was identified in 185 of those cases (Table 6)and it was most commonly identified as being from thecystic duct stump followed by a leak from the liver bed andthen from an accessory duct of Luschka [1, 4–6, 11–13, 16,18, 20–23, 25, 29–31, 33, 36, 38, 42, 43, 53, 59–62, 65–68,70–72]. It should be noted that 20 ‘‘leaks’’ were reportedfrom the common bile duct or common hepatic duct. Theactual pathology in these cases is unknown to these authorsand could actually represent bile duct injury. However, weare reporting what was described by the original authors ofthose series.

The treatment of the 401 bile leaks was similarly evalu-ated (Table 7) [1, 4–6, 11–13, 16, 18, 20–23, 25, 29–31, 33,36, 38, 42, 43, 53, 59–62, 65–68, 70–72]. In only 103 cases(25.6%) was there sufficient data given regarding manage-ment. Of these 103 patients, the most common procedurewas drainage of the leak either by percutaneous, or surgical,or endoscopic methods (74.8%). The remaining 26 patientsin this group underwent ligation of the cystic duct stump(11), ligation of an accessory duct (three), or expectant man-agement with spontaneous resolution (12).

Once again, since the majority of cases were not suffi-ciently detailed, it is difficult to analyze this data in terms ofsuccess rates. Of the 103 cases reporting therapy for bileleaks, there were only three failures indicated (2.9%) [11,31, 70].

Potential predisposing factors for iatrogenic bile ductinjuries and bile leaks are noted in Table 8. Anatomicalvariations, such as a short or absent cystic duct, a cystic ductarising from the right hepatic duct, and an aberrant or ac-cessory right hepatic duct along with acute or chronic in-flammation and tenting of the common bile duct are prob-ably the most common causes of injury. Additionally, at-tempts to control hemorrhage or inaccurate placement ofmetal clips on the cystic duct are other potential predispos-ing risk factors.

Within this large series of 114,005 cases, IOC was at-tempted in 41.5% (4,637 of 11,175) with a success rate of82.7% (60–97%) [4–6, 12, 16, 18, 30–32, 36, 38, 45, 61, 65,66, 68, 71]. Additionally, several studies reported perform-ing IOC; however, it is uncertain whether these were suc-cesses or failures [1, 21–23, 42, 49, 59, 62].

The use of laser or electrocautery dissection was evalu-ated in 12,686 cases [5, 11–13, 16, 22, 25, 29, 30, 36, 38, 49,

Table 3. Location of bile duct injury (N 4 561)

Location Number (%)

CBD/CHD 343 (61.1)Hole, laceration, misapplied clips, cannulation ofCBD, other not specified

Cystic duct 101 (18.0)Hole, laceration, avulsion

Abberant duct 48 (8.6)RHD/LHD 10 (1.8)

Hole, laceration, misapplied clips, other not specifiedTransection of CBD 8 (1.4)Ampullary disruption 1 (0.2)

Subtotal 511Site not specified 50 (8.9)

Abberent duct, anomalous duct; CBD, common bile duct; CHD, commonhepatic duct; LHD, left hepatic duct; RHD, right hepatic duct.

Table 4. Repair of 561 bile duct injuries

Proceduredone Number

Biliary-enteric anastamosis (Hepatico- orcholedochojejunostomy)

76

Laparotomy with T-tube or stent 50Laparotomy with primary suture repair 28Choledochoduodenostomy 8End-to-end anastamosis 8Clip removal 7Endoscopic or percutaneous stent placement 5

Subtotal 182 (32.4%)Not specified 379

Total 561

Table 5. Immediate vs. delayed repair of bile duct injuries

Repair done Immediate Delayed

Primary repair with or without drainage 26 2Biliary-enteric anastamosis 8 16Choledochoduodenostomy 2 1Clip removal 1 1Not specified 7 2

Total 44 22

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59–61, 66, 68, 72]. Electrocautery was used in 10,112 dis-sections (79.7%) and a potassium titanyl phosphate (KTP)or neodymium:yttrium aluminum-garnet (Nd:YAG) laserwas used in 2,574 patients (20.3%). It was not possible todifferentiate whether the laser or electrocautery was respon-sible for bile duct injury or leak in these reported series.

In reviewing this series of laparoscopic cholecystecto-mies, 26,450 cases were analyzed whose reports specificallyrecorded morbidity data [1, 5, 6, 12, 13, 16, 18, 19, 21–23,25, 29–31, 33, 36, 38, 42, 43, 45, 53, 59–62, 65–68, 71, 72].Morbidity, excluding bile duct injuries and leaks, occurredin 1,430 cases for an overall complication rate of 5.4%. Themost commonly reported problems were shoulder pain in226 patients (0.8%), persistent nausea and vomiting in 177patients (0.67%), bleeding in 123 cases (0.47%), woundinfection in 118 patients (0.45%), prolonged ileus in 100cases (0.38%), fever of unknown origin in 90 patients(0.34%), and pulmonary complications in 73 patients(0.28%). Less frequent complications included urinary re-

tention (0.23%), cardiac disease (0.17%), retained CBDstones (0.15%), persistent abdominal pain (0.14%), andsmall- or large-bowel injury (0.1%). Therefore, it is con-cluded that the complication rate is similar to open chole-cystectomy [44].

In this series, 108,837 patients were reviewed in whichmortality was specifically reported [1, 4–6, 11–13, 16, 18–23, 25, 29–31, 33, 36, 38, 42, 43, 45, 49, 53, 60–62, 65, 67,68, 71, 72]. A total of 70 deaths occurred in this group(0.06%) of which 32 (0.03%) were recorded as being di-rectly related to LC. The most commonly reported causes ofdeath overall were heart disease, cerebrovascular accidents,and pulmonary disease. In those patients whose death wasrelated to LC, the most common causes were bile duct in-jury (20) or sepsis due to a missed injury to the small bowelor colon (seven).

Discussion

Although bile duct injuries can occur during various surgi-cal procedures such as gastrectomy, hepatectomy, or porto-caval shunt, 80% of the injuries develop during biliary tractsurgery, especially cholecystectomy [9]. Early papers onlaparoscopic cholecystectomy [41, 49, 52, 64, 68, 74] re-ported a high incidence of bile duct lesions ranging from 0.0to 2.0%. In this review the incidence of bile duct injury ishigher than in open cholecystectomy (0.1–0.25%) [2, 27,44] but it should be noted that this is a 6-year review in-cluding reports during the early learning phase of this pro-cedure. From the data we have reviewed, it cannot be de-termined whether bile duct injury and bile leaks in largeseries overlap with earlier reports by the same author. Inaddition, later series often include data from 1989 to 1995,thus potentially including higher and lower rates of injury.This problem can more likely be better evaluated by a pro-spective study in which the years studied are completelyseparated. In this report, the occurrences of bile duct injuries(0.50%) and bile leaks (0.38%) were separated thus makinga distinction between these two problems. It appears that theearly reported high incidence of bile duct injury could bedue to the inclusion of bile leaks together with bile ductinjuries.

The high incidence of bile duct lesions in the early re-ported series could also be related to the learning curve inlaparoscopic cholecystectomy. Data collected by Woods etal. [73] suggest this hypothesis since they noticed that withincreasing experience there was a decreased number of in-juries. In the series reported by Andren-Sandberg et al. [2]in open cholecystectomy, 85% of the injuries were causedby a surgeon who had performed less than 100 cholecys-tectomies. In laparoscopic cholecystectomy, the SouthernSurgeons Club [68] has shown a 2.2% incidence of bile ductinjuries during the first 13 cases operated on by each sur-gical group and a decrease to 0.1% in subsequent patients.In the series reported by Deziel et al. [20], a significantdifference (p < 0.001) in laparoscopic-related bile duct in-juries was reported when comparing the institutions that hadperformed more or less than 100 operations. Therefore, itmay be concluded that the learning curve may be longerthan the previously considered 10–20 laparoscopic chole-cystectomies.

Besides the experience of the surgeon, anatomical varia-

Table 6. Location of bile leak (N 4 401)

Location No. (%)

Cystic duct stump 102 (25.4)Liver bed/gallbladder fossa 38 (9.5)Accessory duct of Luschka 24 (6.0)CBD/CHD 20 (5.0)Liver biopsy site 1 (0.2)

SUBTOTAL 185Site not specified 216 (53.9)

Table 7. Repair of 401 bile leaks

Procedure No.

Drainage 57Percutaneous—41Laparotomy—10Laparoscopy—3Drain placed at LC-4

Cystic duct ligation 11Accessory duct ligation 3ERCP with stent placement 10ERCP with nasobiliary tube placement 5ERCP with sphincterotomy 5Expectant management 12

Subtotal 103 (25.6%)Laparotomy—management not specified 150Laparoscopy—management not specified 18ERCP—therapy not specified 17Therapy not specified 113

Total 401

Table 8. Potential predisposing factors in bile duct injuries and bile leaks

Anatomical variationsAbsent or short cystic ductCystic duct arising from RHDAberrant or accessory RHD

Acute or chronic inflammationAttempt to control hemorrhageImproper technique

Tenting of CBDImproper placement of metal clips on the cystic ductHole made in cystic or common ducts during dissection

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tions play an important role in the development of bile ductinjuries. According to Smadja and Blumgart [63], the cysticduct drains diagonally and laterally into the common bileduct in 75% of the cases, whereas in 20% of the patients, thecystic duct runs parallel to the bile duct. In the remaining5%, the cystic duct passes posterior to the common bile ductbefore entering the distal left side of the common bile duct.In a large series including 600 patients, Berci [7] foundsimilar anatomical variations but with different incidences.Other congenital anomalies have been reported and all ofthis data indicates the high degree of anatomical variabilityin this region. These factors are also complicated by acutecholecystitis and chronic fibrosis, which emphasizes the ne-cessity of careful surgical dissection.

Moossa et al. [46] support the idea that tissue dissectionwith the laser is more dangerous than electrocautery. In fiveof six patients in their series, a segment of bile duct was‘‘vaporized’’ by the laser. The prospective analysis of theSouthern Surgeons Club [68], however, did not show anydifference in the incidence of bile duct injury using eitherelectrocautery or laser. In this regard, the use of either laseror electrocautery or even the application of metal clipsaround the bile duct can compromise its blood supply bydamaging the nutrient arteries running in the 3:00 and 9:00o’clock positions of the bile duct thus leading to bile ductinjury or late stenosis [40].

In addition, various technical maneuvers are importantto prevent bile duct injury. These considerations includeadequate dissection of Calot’s triangle and accurate identi-fication of the gallbladder–cystic duct junction as well asthe cystic duct–common bile duct junction. It is also impor-tant to laterally retract the gallbladder neck so as to mini-mize tenting of the common bile duct, which can lead to itsinjury [10, 58]. In addition, acute cholecystitis and a shortcystic duct are other important potential predisposing fac-tors for bile duct injury.

Another possible cause of bile duct injury is incorrectplacement of metal clips impinging on the wall of the com-mon bile duct. This may lead to partial or complete bile ducttransection and/or late stricture formation. Complete bileduct transection has been reported in some series to occur in45.5 to 72.7% of all bile duct injuries [10, 28, 58]. Thesereports specifically address CBD injury in major tertiaryreferral centers, and lesser bile duct injuries may not havebeen referred to that institution. However, in this series,only eight of 561 bile duct injuries (1.4%) were noted to becomplete transection. Therefore, it should be noted thatbased on our review, the majority of injuries may be man-aged with procedures less complicated than a biliary entericanastamosis.

The role of intraoperative cholangiography (IOC) inpreventing bile duct injuries has been previously discussed[12, 24, 57, 73]. Some investigators [12] have argued thatIOC may increase the incidence of injury to the commonbile duct, whereas other authors [24, 57, 73] believe thatIOC is useful in identifying anatomical variations and bileduct injury. In this series, 41.5% of the patients had IOCperformed with an 82.7% success rate. However, it cannotbe concluded from this data whether or not the performanceof IOC offers early detection of bile duct injuries, althoughit is very useful in identifying anatomical variations andcholedocholithiasis. Since IOC is performed early in the

gallbladder dissection, it may be postulated that in thosepatients who have complete transection of the common bileduct that it may not be detected because the injury occursafter the IOC is performed.

Bile duct injuries that result in bile duct stricture havebeen classified by Bismuth [9] into five types according totheir location in relationship to the hepatic duct bifurcation(Table 9). As he has reported, type II strictures were themost common (27–38%). Type III injuries accounted for20–33%, type I 18–26%, type IV 14–16%, and type V 0–7%[39]. In a recent multicenter study of 81 patients with lap-aroscopic bile duct injury [73], similar frequencies of stric-tures were encountered. Moossa [46] reported in his seriesof six patients that 50% were type II strictures. In our re-view, it was found that the common bile duct/common he-patic duct were the most frequently injured structures(61.1%), which is consistent with other reported series [9,46, 73].

Immediate recognition and repair of bile duct injury isbelieved to be associated with the best long-term result.Recently, a group of investigators [28] compared laparo-scopic and open cholecystectomy cases in regard to theincidence of early vs delayed detection and short-term re-sults after treatment. They did not find any significant dif-ference in the incidence of bile duct lesions, nor was thereany difference in short-term results of therapy.

Bile duct lesions recognized postoperatively have beenmost frequently managed with biliary-enteric anastomosis.Nonsurgical treatment by ERCP, or papillotomy and place-ment of an endoprosthesis, or by percutaneous transhepaticcholangiography with stent placement are other optionswhich can be used in less complicated cases or in patientswho are poor operative candidates. In a series of 29 patientsby Huibregtse et al. [34], 27 (93%) were successfullytreated endoscopically. Greenen et al. [26], also reportedexcellent results in 88% of his patients with a mean followup of 4.5 years. On the other hand, Pitt et al. [56] comparedsurgical repair with percutaneous transhepatic techniquesand found a much higher success rate with surgery (88% vs55%, respectively). This data indicates that the wide varietyof treatment options and which therapy is chosen may de-pend on the resources at one’s institution.

In the present series, bile leaks were most frequentlymanaged by percutaneous, endoscopic, or laparoscopy/laparotomy drainage techniques. Recently, Peters et al. [54]reported their results with the endoscopic treatment of lap-aroscopic-related bile leaks. Among their 15 patients, endo-scopic treatment was performed in nine cases, and all ofthese cases were successfully treated. In another series byKozarek [37] evaluating the endoscopic management of bileleaks, common bile duct strictures, and fistulas, 86.5% ofthe cases had successful resolution of their problem. It ap-pears from this data that the best initial treatment is endo-

Table 9. Bismuth classification of biliary stricture

1. Low common hepatic duct stricture—hepatic duct stump > 2 cm2. Mid common hepatic duct stricture—hepatic duct stump < 2 cm3. Hilar stricture with no residual common hepatic duct—hilar con-

fluence intact4. Destruction of hilar confluence—right and left ducts separated5. Involvement of aberrant right sectoral duct alone or including com-

mon duct

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scopic and/or percutaneous drainage, but surgical interven-tion may be necessary in more complicated cases.

In conclusion, the incidences of bile duct injuries andleaks in this series are slightly higher than for open chole-cystectomy. With increased surgical experience in laparos-copy, it is anticipated that these incidences will continue todecrease. It is very important that these complications beidentified and treated early as immediate repair is mostlikely to achieve the best long-term results. If there is anydoubt regarding the operative findings, the surgeon shouldnot hesitate to convert a laparoscopic cholecystectomy to anopen procedure. More importantly, however, every effortshould be made to prevent the occurrence of bile duct in-juries by thorough knowledge of the anatomy and by carefulsurgical technique.

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Total radiated power, infrared output, and heat generation by coldlight sources at the distal end of endoscopes and fiber optic bundle oflight cables

C. Hensman,1 G. B. Hanna,1 T. Drew,2 H. Moseley,2 A. Cuschieri1

1 Department of Surgery, Ninewells Hospital and Medical School, University of Dundee, Dundee, Tayside DD1 9SY, Scotland2 Directorate of Medical Physics, Ninewells Hospital and Medical School, Dundee, Tayside DD1 9SY, Scotland

Received: 10 March 1997/Accepted: 1 August 1997

AbstractBackground:Skin burns and ignition of drapes have beenreported with the use of cold light sources. The aim of thestudy was to document the temperature generated by coldlight sources and to correlate this with the total radiatedpower and infrared output.Methods:The temperature, total radiated power, and infra-red output were measured as a function of time at the end ofthe endoscope (which is inserted into the operative field)and the end of the fiber optic bundle of the light cable(which connects the cable to the light port of the endoscope)using halogen and xenon light sources.Results:The highest temperature recorded at the end of theendoscope was 95°C. The temperature measured at the op-tical fiber location of the endoscope was higher than at itslens surface (p < 0.0001). At the end of the fiber opticbundle of light cables, the temperature reached 225°Cwithin 15 s. The temperature recorded at the optical fiberlocation of all endoscopes and light cables studied rose sig-nificantly over a period of 10 min to reach its maximum (p< 0.0001) and then leveled off for the duration of the study(30 min). The infrared output accounted only for 10% of thetotal radiated power.Conclusions:High temperatures are reached by 10 min atthe end of fiber optic bundle of light cables and endoscopeswith both halogen and xenon light sources. This heat gen-eration is largely due to the radiated power in the visiblelight spectrum.

Key words: Infrared output — Heat generation — Coldlight source

In 1877, Nitze constructed a cystoscope with an internallight source consisting of a heated platinum wire and acooling system. Later on, the platinum wire was replaced byEdison’s incandescent lamp to provide better illuminationwithout the need for a cooling system [3]. The introductionof optical light fibers in 1955 permitted the use of high-intensity external light sources without exposing the internalorgans to high temperature [4, 5]. Halogen or xenon lightsources with in-built heat filtering systems, referred to as‘‘cold’’ light sources, are currently used in minimal accesssurgery (MAS). The total radiated power of cold lightsources consists mainly of electromagnetic waves in thevisible light and infrared spectrum as halogen and xenonlamps are not efficient emitters of UV radiation [6]. Ther-mal hazards such as skin burns and ignition of drapes havebeen reported with the use of such cold light sources [1]. Todate, there has been very little reported data on the tem-perature generated by cold light sources used in MAS. Theaim of the study was to document the temperature generatedby cold light sources at the end of endoscopes and fiberoptic bundle of light cables and to correlate the heat gen-eration at these sites with the total radiated power and in-frared output.

Materials and methods

The illumination system consisted of halogen and xenon light sourcesconnected to endoscopes via standard fiber optic cables. The temperature,total radiated power, and infrared output were recorded at the end of theendoscopes and the fiber optic bundle of light cables.

Equipment

Video-endoscopic system.The light sources used in the study were (1)halogen video cold fountain (model 450 BV) containing a 250-W halogenlamp and (2) xenon video cold light fountain (model 615 B) containing a175-W xenon lamp.Correspondence to:A. Cuschieri

Surg Endosc (1998) 12: 335–337

© Springer-Verlag New York Inc. 1998

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The fiber optic cables, all 180 cm in length, were (1) 3.5 mm (model495 NL), (2) 4.8 mm (model 495 NB), and (3) 4.8 mm (model 495 NB DP).

The following endoscopes were studied: (1) a Hopkins II 0° directionof view (model 26003 AA), (2) a Hopkins I 0° direction of view (model26033 AP), (3) a Hopkins I 0° direction of view (model 26033 APA), (4)a Hopkins I 30° (model 26033 BPA), and (5) a Hopkins I 45° direction ofview (model 26033 FPA). All endoscopes were 10 mm in diameter.

The endoscopes, light sources, and fiber optic cables were all newequipment (Karl Storz, Tuttlingen, Germany).

Total radiated power and infrared measuring system.The total radiationpower was measured by the Ophir Energy system and Thermopile (modelDGX, Optronics Ltd., Tel Aviv, Israel). An infrared pass filter whichtransmits only infrared radiation (model 03MCS005, Melles Griot, Cam-bridge, England) was utilized in conjunction with the thermopile to mea-sure infrared output.

Temperature recording.The system consisted of a thermocouple (RS,Brighton, UK) connected to a computer card and software (Amplicon PC73 A, Boston Technology, Boston, USA) configured on a Dell316SXpersonal computer (Dell Computer Corporation, Berkshire, England) run-ning on a digital operating system.

Experimental procedure

Two experiments were performed. In the first experiment, temperature,total radiated power, and infrared output were recorded at the distal end ofthe endoscopes using both halogen and xenon light sources with 3.5-mmand 4.8-mm light cables. The temperature at the end of the endoscopes wasmeasured both at the lens surface and at the optical fiber location (Fig. 1).In the second experiment, the temperature, total radiated power, and in-frared output were measured at the end of the fiber optic bundle of threelight cables connected to halogen and xenon light sources (Fig. 1). Thesemeasurements at the end of the fiber optic bundle were obtained with thelight cable not connected to the light port of the endoscope.

In both experiments, endoscopes and cables were secured to a clampstand, and the thermocouple for the temperature recording was placed onthe site being studied. On each occasion the temperature measurement wasobtained immediately following disconnection of the light cable from thelight source in order to prevent light absorption directly heating the ther-mocouple. The temperature was recorded at 15-s and 10-, 20-, and 30-minintervals from the opening of the iris of the light source. Measurement oftotal radiated power and infrared output was obtained at 10 min. Duringthese experiments, the room temperature was kept constant at 26°C. Bothexperiments were conducted in triplicate.

Results

Endoscopes

The highest temperature recorded was 95°C. The tempera-ture measured at the optical fiber location was higher than atthe lens surface (p < 0.0001,t-test for independent samples).The temperature recorded at the optical fiber location rosesignificantly in all endoscopes up to 10 min (p < 0.0001,t-test for paired samples) and was then followed by a steadystate for the period studied, next 20 min (p 4 0.7, t-test forpaired samples). The difference in the temperature and totalradiated power between different endoscopes was not ac-counted for by a significant difference in infrared output(Table 1). The temperature recorded at 10 min correlatedbetter with total radiation power (correlation coefficient 0.6,p < 0.0001) than with infrared output (correlation coeffi-cient 0.4,p < 0.001).

Light cables

The highest recorded temperature at the end of the fiberoptic bundle of light cables was 239°C. The temperaturereached 225°C within 15 s. Again, there was a significantrise in the temperature recorded during the first 10 min (p <0001, t-test for paired samples). Table 2 shows the meanand standard deviation of the temperature, total radiatedpower, and infrared output at the end of the fiber opticbundle of light cables.

Light sources

The temperature, total radiation power, and infrared outputat the fiber optic bundle of light cables are shown in Table3. Although the halogen light source employed a more pow-erful lamp (250 W) than that of xenon source (175 W), therewas no significant difference in the temperature or totalradiated power at the light cables or endoscopes between thetwo light sources. However, the infrared output at the fiberoptic bundle of the light cables and endoscopes was higherwith the xenon light source than with the halogen source (p< 0.0001,t-test for independent samples).

Discussion

The present study has documented high temperatures pro-duced by cold light sources. These reach 95°C at the end ofthe endoscope and 239°C at the fiber optic bundle of lightcables. Most of the temperature rise occurs during the first15 s of opening the iris of the light source. The heat gen-eration is largely caused by the radiated power in the visiblespectrum as infrared component accounts for only 10% ofthe light energy. Furthermore, the temperature rise corre-lates better with total radiation power than with infraredoutput. This means that cold light sources have efficientheat filters to reduce the infrared output. As the temperatureis caused by the radiated power in the visible spectrum, theheat production by current light sources and fiber optic lightcables can be reduced only at the expense of illumination.Further research is required into the light absorption char-acteristics of fiber optic light cables especially at the distalend in order to produce adequate illumination with less heatproduction. The incorporation of the charged coupled de-vices (CCDs) at the distal end of the endoscope (opto-electronic endoscope) by permitting use of less powerfullight sources will reduce heat generation with adequate il-

Fig. 1. Experimental setup. In experiment I, measurements were obtainedat the end of the endoscope, while in experiment II measurements weretaken at the end of the fiber optic bundle of the light cable without beingconnected to the endoscope.

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lumination of the operative field. The ultimate solution tothe heat problem is the design of a self-illuminating endo-scope based on an array of light-emitting diodes. This is amuch more efficient system and will dispense with the needfor powerful extrinsic light sources and connecting lightcables.

The data from this study have also demonstrated moreheat generation at the optical fiber location near the distalend of the endoscope than at the lens surface. This tempera-ture differential accounts for the fogging of the lens bycondensation from intraperitoneal water vapor on the rela-tively cool surface of the endoscope lens. Fogging obscuresvision and disrupts the progress of the procedure. The mostcommonly used methods to overcome this problem includethe use of antifogging agents and pre-warming with drylaparoscope heaters or simple immersion in warm sterilewater. The hydrolaparoscope (Circon AC-MI, Stanford,

CA, USA) and stereoendoscope used in transanal endo-scopic microsurgery (Wolf, Knittlingen, Germany) have in-tegrated irrigating channels designed to clear the optic whencondensation occurs. The Tubingen multifunction laparo-scope utilizes a separate electrical heating element to warmthe optic together with warm humidified CO2 jet whichstreams across the lens to dry it [2] but this is a complex andunwieldy setup and has not proven popular. A simpler ap-proach based on the observations from the present study isto deploy some of the thermal energy produced at the distalend of the endoscope to warm the surface of the lens andprevent fogging. This may be achieved by directing some ofthe optical fibre bundles onto the periphery of the lens sur-face, acting as an automatic lens warming system.

There are other clinical implications of the study sincesuch high-temperature levels may result in skin burns orignition of drapes. Both surgeons and nurses should bemade aware of thermal hazards associated with the use ofvideo-endoscopic systems.

References

1. Bellina JH, Haas M (1984) Cold light sources—are they really cold? JReprod Med 29: 275–277

2. Bessell JR, Fleming E, Kunert W, Buess G (1996) Maintenance of clearvision during laparoscopic surgery. Min Invas Ther 5:450–455

3. Casper DL (1906) Physical methods of examination. In: Casper DL,Bonney CW (eds) A text-book of genito-urinary diseases. Rebman,London, pp 11–54

4. Heel ACS (1954) A new method of transporting optical images withoutaberrations. Nature 173: 39

5. Hopkins HH, Kapany NS (1954) A flexible fibrescope. Nature 173:39–41

6. Mosely H (1983) Sources of ultraviolet radiation. In: Mosely H (ed)Non ionising radiation. Adam Higler, Bristol, UK, pp 110–113

Table 1. Temperature, total radiated power, and infrared output at the end of endoscopes, mean and (standard deviation)a

Endoscopes 0 H I (AP) 0 H II (AA) 0 H I (APA) 30 H I (BPA) 45 H I (FPA) p* value

Temperature at 15 s (°C) fiber location 64.96 60.54 67.08 88.63 59.04 <0.05(15.43) (16.56) (13.89) (42.30) (14.77)

Temperature at 10 min (°C) at fiber location 69.74 66.14 77.03 95.04 65.20 <0.05(17.95) (19.57) (19.57) (41.92) (14.46)

Temperature at 10 min (°C) at lens surface 35.61 35.93 36.38 36.68 36.15 40.2(1.02) (0.85) (1.14) (1.45) (1.08)

Total radiated power (Watts) at 10 min 1.0408 1.3450 1.5058 1.1242 0.8858 <0.05(0.4079) (0.5012) (0.7689) (0.4081) (0.5010)

Infrared output (Watts) at 10 min 0.0808 0.1042 0.1442 0.09442 0.0925 0.5(0.0676) (0.0944) (0.0989) (0.0776) (0.1067)

* p value on applying one-way ANOVA.a (H) refers to Hopkins followed by letters between parentheses to indicate the model.

Table 2. Temperature, total radiated power, and infrared output at the fiber optic bundle of light cables,mean and (standard deviation)

Light cables 3.5 mm 4.8 mm 4.8 mm (DP) p* value

Temperature at 15 s (°C) 163.75 180.50 225.00 <0.01(7.50) (22.53) (0.58)

Temperature at 10 min (°C) 174.00 191.75 239.25 <0.01(10.98) (32.62) (13.74)

Total radiated power (Watts) at 10 min 1.5025 3.5800 3.7300 <0.0001(0.2743) (0.2743) (0.4516)

Infrared output (Watts) at 10 min 0.1300 0.3175 0.3675 40.2(0.0983) (0.1935) (0.2165)

* p value on applying one-way ANOVA.

Table 3.Temperature, total radiated power, and infrared output at the fiberoptic bundle of light cables, mean and (standard deviation)a

Light sources Halogen Xenon p* value

Temperature at 15 s (°C) 186.00 177.17 40.4(22.1359) (18.5302)

Temperature at 10 min (°C) 204.00 199.33 40.7(30.82) (41.02)

Total radiated power (Watts) 2.6450 3.2300 40.4at 10 min (1.0693) (1.0693)

Infrared output (Watts) at 10 min 0.1250 0.4183 <0.001(0.0635) (0.1607)

* p value of applying one-way ANOVA.a Halogen light source employs a 250-W lamp while xenon source uses175-W lamp.

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Original articles

Biliary tract complications in laparoscopic cholecystectomy

A multicenter study of 148 biliary tract injuries in 26,440 operations

J. Regoly-Merei, M. Iha sz, Z. Szeberin, J. Sa´ndor, M. Ma te

3rd Surgical Department, Semmelweis Medical University, H-1096, Budapest, Nagyva´rad ter 1, Hungary

Received: 1 March 1996/Accepted: 26 November 1996

AbstractBackground:The higher risk of biliary tract injury is con-sidered the most significant disadvantage of laparoscopiccholecystectomy.Methods:A national multicenter retrospective study wasperformed to determine the frequency, etiology, and treat-ment of biliary tract injuries between January 1, 1991, andDecember 31, 1994. Follow-up was by questionnaire.Results:Some 148 biliary tract complications were ob-served during 26,440 laparoscopic cholecystectomies.There was no significant correlation found between thenumber of LCs performed in one institute and the incidenceof biliary tract injuries and postoperative bile leakage, but inthe 2nd year of practice, the incidence of both complicationsdecreased. In institutes with more conversions, more casesof bile leakage were also observed. A significant positiverelationship was found between biliary tract injuries andpostoperative bile leaks. There was no significant relation-ship between usage of intravenous and intraoperative chol-angiography and ERCP. In univariant analysis of the type ofinjury, the primary treatment modality did not affect theoutcome of injury or entail the necessity of reoperation.Obscure anatomy leads to significantly more main bile ductinjuries. According to multivariant analysis, the outcome issignificantly influenced unfavorably by the necessity of re-peated interventions and advanced age.Conclusions:The definitely higher risk of bile duct injurymentioned in early studies was not confirmed.

Key words: Laparoscopic cholecystectomy — Biliary tractinjury — Postoperative bile leak — Biliary tract reconstruc-tion — Conversion

Laparoscopic cholecystectomy (LC) has been become wide-spread since 1989, and today it is the standard method fortreating cholecystolithiasis. The first procedures in Hungarywere performed in December 1990 and it is now used inalmost 90 institutes there. Compared to traditional opencholecystectomy (OC), the higher risk of biliary tract injuryis considered the most significant disadvantage of thismethod. The incidence of these injuries was higher in theearly reports (1990–1992) than in later ones (1993–1995),as experience in LC, patient selection criteria, and operativetechnique fundamentally determine the frequency of lesions[3, 4, 6, 8–10, 14, 16, 19–22, 26].

The role of nonoperative, invasive radiological, and en-doscopic methods in the treatment of biliary tract injuriesand the comparison of their success with the operative re-sults are debated issues. Is primary suture over a T-tube orbilio-enteric anastomosis the treatment of choice at recon-struction? Which factors determine the outcome of injuryand the risk of repeated operations? These questions shouldbe investigated in multicenter studies with a large number ofpatients. Data of institutes with different experience in per-forming LC give a more realistic picture of the method thanif we only examine the results of departments with greatexperience.

Patients and method

In February 1995, questionnaries were sent to 119 Hungarian surgicaldepartments with the assistance of the Hungarian Surgical Society. Theobjective of this retrospective study was to determine the frequency, eti-ology, and treatment of biliary tract complications of LC between January1, 1991, and December 31, 1994. According to the 105 responses werereceived, LC was not performed in 16 institutes; therefore we analyzed thedata of 89 surgical departments. It comprises 95% of all laparoscopiccholecystectomies performed in the same time period in Hungary. Ourmain emphasis was laid on studying the possible connection among pre-and intraoperative cholangiography, preoperative ERCP, frequency of con-version, and the biliary tract injuries and spontaneously ceased postopera-tive biliary leaks. The symptoms, the diagnostic methods, the localizationof injuries, the treatment modalities, the type of reoperations, the outcome,and the current status of the patients were analyzed. We registered 148Correspondence to:J. Rego¨ly-Merei

© Springer-Verlag New York Inc. 1998Surg Endosc (1998) 12: 294–300

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biliary tract lesions in 26,440 LCs in the above-mentioned period, but thereal number of injuries could be estimated only in the long-term follow-up.

The data of the questionnaires were analyzed using an IBM-compatiblepersonal computer. Lotus software was used to log and monitor the dataand SPCC/PC+ was used for analysis. Statistical correlations were exam-ined using regression analysis. The Studentt-test was used for the analysisof significant differences in the case of continuously changing factors, andthe Fischer exact testx2-test were used in the case of discrete variables.The multivariant examination was performed using Wilks discriminantanalysis.

The most important topics examined are:

1. The role of experience in LCs, the incidence of conversions, the use ofintraoperative cholangiography and preoperative diagnostic tests (pre-operative cholangiography and ERCP) in the prevention of biliary com-plications

2. The effects of location of the lesion, their primary repair, and the timeof the diagnosis on the outcome (frequency of reoperations, mortality,postoperative complaints, etc.)

3. The suspected mechanism of injuries, the method of diagnosis, and thesymptoms

Results

Analysis of institutional data

In the period examined, 26,440 cholecystectomies were per-formed laparoscopically (the total number of cholecystec-tomies was 55,605) in 89 institutes; the LCs were 48% of allcholecystectomies. Although the national average is 297 ±418 LCs institute, there were less than 50 procedures per-formed in 21 departments and less than 300 in another 29,meaning that these institutes are in the learning phase.Twenty-nine departments have had more than 300; threedepartments performed more than 1,000 and two more than2,000 operations. The great variety of data made the analy-sis difficult, so in several instances we performed the analy-sis using different statistical methods to reduce the possi-bility of bias.

In Table 1 we summarize LCs, the nationwide and in-stitutional rate (mean ± SD) of conversion, pre- and intra-operative cholangiography, ERCP, and biliary tract injuriesand postoperative bile leaks. It is to be noted that preopera-tive cholangiography was used in only 32, preoperativeERCP in only 50, intraoperative cholangiography in only 33institutes. Conversions were necessary in 81 departments;biliary tract injury was reported from 56 and postoperativebile leak from 68 departments. The data in an annual break-down showed that the use of preoperative intravenous chol-angiography decreased continuously (15% in 1991, 5.1% in

1994), while the frequency of ERCP increased somewhat(1.4% and 4.5%, respectively, in the same years).

There was no significant connection between percentageof LCs and the rate of conversion among the institutes.There was a wide range of figures among the different in-stitutes (conversion: 0 to 32.4%, average ± SD: 6.5 ± 5.5%);therefore, the regression curve between the absolute numberof LCs performed in 1 year and conversions was examinedalso. It was realized that the regression coefficient of thecurve decreased significantly in the 2nd year of practice (p< 0.05, t 4 2.082), meaning that as more experience wasgained, less conversions were associated with the samenumber of operations (Fig. 1).

No significant correlation was found between the per-centage of biliary tract injuries and the absolute number ofLCs performed in the same institution, the incidence ofconversions, the frequency of intra- and preoperative chol-angiography, and ERCP. However, when the correlationbetween the absolute number of biliary tract injuries and theabsolute number of LCs performed was evaluated, we foundthat although the higher number of procedures is connectedwith a higher risk of lesions, the coefficient of the regressioncurve decreased significantly in the 2nd year compared withthe 1st year, and in the 3rd year there is no more significantcorrelation between the two parameters (Fig. 2). A signifi-cant correlation was found between biliary tract injuries andthe postoperative bile leaks that ceased spontaneously (p <0.05,r 4 0.228). The latter also showed positive correlationwith the frequency of conversions (p < 0.001,r 4 0.356),but it was not in significant correlation with the number ofLCs performed, with the incidence of the use of intra- andpreoperative cholangiographies, or with ERCP. Evaluatingthe absolute numbers of LCs performed and bile leaks inconnection with the year of practice, we found similar cor-relations, as in the case of biliary tract injuries, i.e., thecoefficient of the regression curve decreased as experiencewas gained (1st year/2nd year:p < 0.001,t 4 10.222, 1styear/3rd year:p < 0.001,t 4 9.9009 (Fig. 3).

Detailed analysis of 148 biliary tract complications

In the course of the 26,440 LCs, 29 male and 119 femalepatients suffered biliary tract complications, and the averageage was 48.7 ± 14.7 years (16–84 years). The injuries weredetected intraoperatively in 34.5% (n 4 51) and conversionwas performed in 50 cases. In one case, a small, point-likeinjury was drained and the patient was closely observed.

Table 1. Summary of Hungarian data

Nationwide data

Institutional

Average ± SD Minimum Maximum

Number of LCs 26,440 297 ± 418 3 2405Conversions 5.9% 6.5 ± 5.6% 0% 32.4%Preoperative cholangiograms 6.9% 8.5 ± 24.8% 0% 100%Preoperative ERCPs 4.1% 3.8 ± 7.3% 0% 40.2%Intraoperative cholangiograms 6.9% 3.9 ± 13.6% 0% 94.5%Biliary tract injuries 0.6% 0.7 ± 0.95% 0% 4.5%Biliary leaks 1.8% 2.2 ± 3% 0% 21.6%

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The injury was postoperatively detected in 65.5% of thecases (n 4 97) on average postoperative day 6 ± 7.6 (1–64).

The different types of biliary complications are shownin Table 2. The partial (type 2) and complete (type 3) inju-ries of the main biliary ducts were detected intraoperativelysignificantly more frequently than injuries of the cystic ductor confluence (type 1). The cases in the latter group (n 439) were usually diagnosed in the postoperative period(conversion: six, postoperative detection:33)(type 1/type2:p < 0.001, type1/type3:p < 0.05). There was no significantcorrelation between the type of injury and the delay of di-agnosis, except in combined injuries, where the diagnosis ismade later (but in the latter group the number of cases isinadequate for statistical analysis).

Clinical signs in 61.9% (spontaneous pain 45.4%, ten-derness 51.5%, fever 26.8%, nausea 24.7%, vomiting15.5%, acute abdomen, guarding 14.4%, other 4%) and bileleak via a drain in 63.9% indicated lesion. In spite of thediagnostic methods (sonography, ERCP, PTC, CT, HIDAcholescintigraphy), in 14.4% of the cases the real etiologyof the symptoms was revealed only at the time of reopera-tion and in one patient only by autopsy.

The primary treatment of the patients is shown in Table3. There were significantly more reoperations and less con-versions in the cases of cystic duct lesions than in the casesof main bile duct injuries. No significant difference, how-ever, were found between the different types of main bileduct injuries (partial lesion, complete transection, excision)with respect to the incidence of conversion and reoperation.In the 148 patients, 50 conversions and 90 reoperations wereperformed primarily; the distribution of these operations issummarized in Table 4. There was not enough data in 5% ofthe patients for accurate classification.

In the 39cystic lesionssix patients (15.4%) were treatedby conversion and 31 (79.5%) by reoperation. One pa-tient—with an intraoperatively inserted drain—was onlyobserved, while another one was drained percutaneously.Cystic stump revision and closure alone were performedwith open surgery in 22 (56.4%) and laparoscopically in one(2.6%) case. Reconstruction over biliary drainage was nec-essary in eight patients (20.5%), while biliodigestive anas-tomosis was done in two (5.1%) patients. Evacuation offluid accumulation and CBD stone extraction combinedwith biliary drainage were performed each in one case, re-spectively. The type of reintervention was not clear in two(5.1%) cases.

In cases ofpartial CBD lesions,reconstruction over aT-tube or other type of drain was performed primarily in 52(69.2%) cases, and bilioenteric anastomosis was performed

Table 3. Primary treatment of biliary tract injuries I

N %

Patients with drains in place, observation 3 2.0EST + stent 1 0.7Percutaneous drainage 2 1.4EST + Stent + percutaneous drainage 1 0.7Conversion 50 33.8Reoperation 90 60.8Diagnosed only at autopsy 1 0.7Total 148 100

Fig. 1. The correlation between the number of conversions and the numberof LCs performed in 1 year.

Fig. 2. The correlation between the number of biliary tract injuries and thenumber of LCs performed in 1 year.

Fig. 3. The correlation between the number of biliary leaks terminatedspontaneously and the number of LCs performed in 1 year.

Table 2. Types of biliary tract complications (n 4 148)

N %

Cystic duct lesion 39 26.4Partial injury of main bile ducts 52 35.1Complete transection of main bile ducts 30 20.3Excision of bile duct 10 6.8Stricture 8 5.4Accessory bile duct injury 3 2.1Combined injurya 4 2.8Unidentified 2 1.4Total 148 100

aInjury + stricture (two cases); excision + lesion of the hepatic artery (onecase); stricture + accessory bile duct lesion (one case)

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in three (5.8%) cases. Evacuation, CBD stone extractioncombined with biliary drainage, laparoscopic reconstruc-tion, EST combined with stent implantation, and percuta-neous drainage were done in one case each. In this group wedid not find any data about the type of reoperation in fourcases (7.7%).

Of the 30 complete CBDtransectionsbilioenteric anas-tomosis was performed in 19 (63.3%) patients and recon-structions over a T-tube were done in ten (33.3%). In onepatient we did not have any information. Bilioenteric anas-tomosis dominated in the treatment ofexcisions(8/10) andstrictures(4/8).

A second interventionbecame necessary in 22 patients(15%) (Table 5), and in half of these (n 4 11) biliodigestiveanastomosis was the choice treatment. Gastrointestinalbleeding and adhesions were the indication for surgery intwo patients. EST with or without stent was performed intwo patients. Only one patient required reoperation amongthe 22 cases with cystic stump suture, drainage, or reclip-ping. Repeated intervention became necessary in eight casesafter biliary reconstruction+drainage and in six patients af-ter previous biliodigestive anastomosis. This does not rep-resent a significant difference between the type of primarysurgery and the necessity for reintervention. Athird inter-ventionwas needed in six patients (4.1%). In one case astent was placed; the type of procedure is not known in onecase, while of the remaining four patients, one biliodigestiveanastomosis was performed and the anastomosis was re-peated in three cases.

Patients recovered completely in 75.7% of the casesfollowing a primary procedure and in 7.4% after a reinter-vention (483.1%). Seven patients expired (4.7%); two ofthem had reintervention. Nine-and-one-half percent (3.4%had one procedure, 6.1% had reintervention) still have com-plaints (meteorism, cholangitis, anastomotic stricture, posi-tive liver function tests). Four patients (2.7%) were trans-ferred to another institute and no data was available on theirfollow-up. Age influenced the outcome significantly; theaverage age of the cured (p < 0.05, t 4 2.213) and thesurvivals with complaints (p < 0.01,t 4 3.380) was lowerthan that of the expired. It took 18.7 ± 20.3 (6–180) days onaverage to recover following one intervention and the samefigure was 31.7 ± 33.1 (5–90) following reintervention. Thisdifference does not attain statistical significance because ofthe wide deviation. There was no significant correlationfound between the outcome (cured/expired and patientswith or without complaints) and the type of injury (cysticduct lesion, partial or complete lesion of main bile duct,excision, etc.) using univariant analysis. Also based on uni-variant analysis, the type of the primary procedure (cysticduct closure alone, bile duct suture over a drain, biliodiges-tive anastomosis) did not significantly influence the ratio ofcure and mortality, but significantly more patients had com-plaints following biliodigestive anastomosis than followingcystic duct closure (p < 0.05).

Evaluating the correlation between the time of cure andprimary procedure, there is no significant difference be-tween cystic duct closure and bile duct suture with or with-out drain, but the recovery is significantly longer in cases ofbiliodigestive anastomosis compared to cystic duct closure(p < 0.01, t 4 2.908). There is no significant differencebetween recovery periods in the cases of bile duct sutureand biliodigestive anastomosis.

Multivariant analysiswas employed to examine thecombined influence ofage, the type of injury(cystic ductlesion, partial or complete transection of a biliary tract, ex-cision, suture),the type of the primary procedure(cysticduct closure, biliary tract reconstruction ± drainage, bilio-digestive anastomosis),the time of diagnosis(intraopera-tive-conversion, postoperative-reoperation), andthe re-peated intervention(yes or no) on the outcome. If the pa-tients were placed in two separate groups of ‘‘cured’’ and‘‘symptomatic + expired,’’ repeated intervention and de-layed diagnosis (reoperation and no conversion) proved tobe significant factors. If they were grouped as ‘‘survivingpatients’’ (with or without complaints) and ‘‘expired,’’ agein the first place and repeated procedure in the second ex-hibited a significant negative effect on the outcome. If weanalyze the data in three separate groups of ‘‘surviving pa-tients without complaints,’’ ‘‘surviving patients with com-plaints,’’ and ‘‘expired,’’ the same two factors were foundto be significant, and repeated procedure takes first placeand age second.

The suspected etiology of biliary tract injuries is listedin Table 6. However, the reason could not be identified in4.1% of the cases. Identification problems were found inalmost half of the cases (43.2%), and combined mechanismswere supposed in 10.1%. Analyzing the correlation betweenthe etiology and the type of injury, it was self-explanatorythat difficulties in applying clips caused significantly more

Table 5. Secondary treatment of biliary tract injuries:n 4 22 (15%)

N %

EST 1 4.5EST + stent 1 4.5Biliodigestive anastomosis 11 50.0Redo of previous anastomosis 1 4.5T-tube ± ligation or suture of cystic stump 3 13.6Other interventions for stricture 1 4.5Abscess drainage 1 4.5Duodenum suture + biliary tract reconstruction + T-tube 1 4.5Lysis of adhesions 1 4.5Vagotomy + excision of ulcer 1 4.5Total 22 100

Table 4. Primary treatment of biliary tract injuries II (Conversion + reop-eration)

N %

Exploration alone 1 0.7Evacuation or drainage alone 3 2.1Treatment of accessory bile ducts 3 2.1Removal or change of clips 3 2.1Treatment of cystic duct, drainage, or

suture of cystic duct angle22 15.7

Suture of bile duct ± T-tube orother drainage

59 42.0

Some form of biliodigestive anastomosis 37 26.4Removal of bile duct stone + T-tube 2 1.4Hepaticojejunostomy + reconstruction

of hepatic artery1 0.7

Laparoscopic cystic duct management 2 1.4Unidentified 7 5.0Total 140 100

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cystic duct complications than main bile duct injuries (p <0.001,x2 4 14.56). Coagulation caused significantly morepartial biliary duct injury than complete transsection (p <0.05, x2 4 4.178). Obscure anatomy caused significantlymore partial (p < 0.001,x2 4 12.33) and complete (p <0.001, x2 4 34.23) biliary tract lesions than cystic ductinjuries or insufficiency and also played a major role incomplete dissections compared to partial lesions (p < 0.001,x2 4 11.99).

In the 148 patients we analyzed, the effect of intrave-nous cholangiography and ERCP (preoperative diagnosis)and intraoperative cholangiography separately as well.There was no significant correlation found (similarly to theinstitutional results) between the usage of the preoperativetests and the incidence of the biliary tract complications.Intraoperative cholangiography was performed significantlymore often in the case of injuries (p < 0.05,x2 4 9.15), butmost likely the cholangiograms were already performedwith the suspicion of bile duct injuries. In the institutionaldata it was shown that intraoperative cholangiography doesnot effect the incidence of biliary tract injuries. Seven pa-tients were lost who suffered biliary tract injury (4.7% mor-tality). In two cases gallbladder carcinoma was partiallyresponsible for the fatal outcome. The cause of death wascardiorespiratory failure in one case, hepatic coma in an-other; the three others died of a septic condition, peritonitis(in one case accompanied with bleeding). We would like toemphasize that one patient was returned to a surgical de-partment a few days following the surgery in a moribundcondition, and he expired within hours. Autopsy revealedthat the cause of death was peritonitis caused by biliary tractinjury.

Discussion

The incidence of biliary tract injuries during LCs rangesfrom 0.2% to 0.9% [3, 6, 7, 9, 10, 13, 16, 21, 22, 26], but inthe early period following its introduction figures of 1.4 to2.9% were also reported [4, 12]. The Hungarian average of0.6% is comparable with international data. Only 24–38%of the biliary tract injuries are detected at the time of thesurgery, and the delay in the diagnosis of lesions varies from1 to 246 days, most frequently 2 to 30 days [1, 3, 4, 9, 20,

23, 25, 28]. The early diagnosis improves if intraoperativecholangiography is used routinely [28].

The incidence of conversion changes from 0.9 to 13% inthe literature, mostly 4 to 4.5%, and one-third of them areperformed acutely [5–11, 21, 22, 26]. Biliary tract injury isthe reason for conversion in 0.2 to 0.3% of the cases. Thesymptoms of biliary tract injury appear often only afterdischarge (the average hospital stay is 24 to 72 h), so familydoctors should be educated to recognize this complication.

There are different classifications of the biliary tractinjuries in the literature. The Bismuth classification is basedon localization [16, 28]; another emphasizes the type ofcomplication (injury, stricture, cholangitis, biliary cirrhosis[20]; and the third—which is probably more useful in thecase of LCs-distinguishes partial/tangential lesions, injuriescaused by clips, complete transections ± excisions and le-sions of the right hepatic duct [20, 23]. In our own practice,we applied the last classification with moderate modifica-tion (see Table 2).

The role of sonography in preoperative diagnostic testsis well known as it decreases operative risks and avoidsbiliary tract injuries [17]. Some teams routinely use preop-erative intravenous cholangiography [8, 11, 18, 26] but themajority avoid this test [10]. The incidence of preoperativeERCP depends on whether laparoscopic revision of thecommon bile duct can be performed in the institute [11, 13,15, 18, 26]. Both methods decrease the incidence of unex-pected biliary tract stones found during LCs, but we did notfind any evidence that the incidence of biliary tract compli-cations and postoperative bile leaks decreases if these twomethods are used more often.

Opinions differ about the routine and selective applica-tion of intraoperative cholangiography [2, 5, 6–8, 9, 11, 18,21, 22, 26]. Dubois et al. [6] state that intraoperative chol-angiography does not facilitate the prevention of biliarytract complications, and they only perform it if there is ahigher risk of a common bile duct stone. Others say that theintraoperative cholangiogram helps to avoid the completingpartial injuries, that lesions can be identified earlier, and thatconversion can be performed. The prognosis is better than inthe case of injuries recognized only postoperatively [28].Obviously injuries may occur following cholangiographydue to a malpositioned clip or during the dissection of thegallbladder from the liver bed. Berci [2] emphasized that theindications for intraoperative cholangiography are differentin traditional and laparoscopic surgery. In the latter case themain purpose is to avoid iatrogenic lesions. In the Hungar-ian data there was no significant correlation between the useof intraoperative cholangiography and the incidence of bil-iary tract injuries and bile leaks.

We should think of biliary tract injury if atypical pain,abdominal distension, vomiting, ileus, or cholangitis is pre-sent in the postoperative period or if peritoneal signs, an-orexia, or pathologic laboratory results are detected [1, 4,19, 25]. In our data, 14.4% of the patients with injuries hadacute abdominal symptoms—peritonitis. Biliary flow viathe intraoperatively placed drain is a very demonstrativesign (63.9%). While sonography and CT prove pathologicfluid accumulation, HIDA, ERCP, and PTC show the lesionitself and the last two methods can also localize the injuries[1, 3, 5, 25, 27, 28].

Several things are responsible for biliary tract injuries

Table 6. Suspected etiology of biliary tract injuries

N %

Malposition or spontaneously slipped clips 21 14.2Injury caused by clips 12 8.1Thermal injurya 19 12.8Identification difficultiesb 64 43.2Technical failure 5 3.4Bile duct stone 4 2.7Carcinoma of the gallbladder 1 0.7Combined mechanism 15 10.1Other 1 0.7Unidentified 6 4.1Total 148 100

aThermal origin was significantly more often seen in partial lesion than incomplete transsectionbIdentification difficulties were significantly more often met in partial orcomplete lesions than in the injury of the region of the cystic duct

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[1, 6, 8, 14, 19]. Obscure anatomy is the dominating factor(43.2%) in our practice. It leads to significantly more partialor complete lesions of the main bile ducts than cystic ductinjury and is also responsible for more complete transectionthan partial lesion. Similar factors are responsible for post-operative bile leaks, as well. We also should mention per-forations caused by cholangiographic catheters and the pos-sible presence of the ducts of Luschka [10, 27]. While thiscomplication occurs in 0 to 0.6% during traditional chole-cystectomies, the incidence is 0.3 to 0.9% in connectionwith LCs [8, 10]. The similar etiology of postoperative bileleak and biliary tract lesion is supported by the Hungariandata. Intraabdominal drainage helps in the early diagnosis ofcomplications and it can be therapeutic, too [10]; however,there are different opinions in the literature about its selec-tive or routine application [5–8, 22].

The best results can be achieved when reintervention isperformed before the appearance of peritonitis and septiccomplication. It is not clear, however, what type of proce-dure should be performed. Some teams emphasize the suc-cess of invasive radiological, endoscopic interventions andrelaparoscopy [3, 4, 24]. If the biliary tract has a goodoutflow, the lesion can heal following the diversion [25].Others report less favorable results, but they think that dueto invasive procedures the patient will reach a better con-dition by the time of the definitive surgery [16, 23, 25]. Thelesions of the cystic duct and liver bed can be treated wellby nonoperative methods [5, 28] and percutaneous drainageis almost always successful in the cases of encapsulatedfluid accumulations [25]. In the Hungarian data, nonsurgicalinterventions were applied as primary treatment in only2.8% of the patients, so conclusions cannot be drawn.

There is always an indication for bilioenteric anastomo-sis in the case of late strictures [16], but it is questionablewhether primary bile duct suture (± biliary tract drainage) orbiliodigestive anastomosis is more advantegous in the earlytreatment. Schol et al. [20] state that the time of diagnosis isalso important besides the severity of injury. End-to-endanastomosis can be performed if a diagnosis is madepromptly, and bilioenteric anastomosis is recommended inthe case of delayed treatment. In our data the primary pro-cedure was determined by the type of the injury.

In our data, bile duct suture over a drain was performedin 59 patients as primary treatment and biliodigestive anas-tomosis was applied in 37 cases. There was no significantdifference between the two groups in the outcome and in-cidence of reintervention, but the neccessity of repeatedinterventions made a significantly negative influence on theoutcome.

Higher age made the prognosis of injury significantlyworse by uni- and multivariant analysis as well; however,the type of injury and the primary treatment did not influ-ence significantly the ratio of the cured and the expiredpatients.

The follow-up studies of biliary tract injuries report a 10to 30% incidence of delayed strictures [16, 27]. These re-sults are based on the experience gained in traditional cho-lecystectomies as the time since the introduction of LC isinsufficient to evaluate the real incidence. Raute et al. [16]state that 65 to 85% of the strictures present in the first 2years and only 5 to 10% of them appear later than 10 years.

The supposed 1 to 2% incidence of biliary tract injuries

in the early phase of LC was not apparent in our experience.On the other hand, 15% of the lesions required reinterven-tion, and the mortality was 4.7%, sofurther prospectivestudies are necessaryto determine the ideal surgical tech-nique to decrease the incidence of injuries and the bestprimary reconstructive protocols.

Acknowledgments.We thank Agnes Zo´randi for her hard work in thestatistical analysis. We thank our colleagues in all participating surgicaldepartments for supplying data on patients and for taking part in thisnational survey.

References

1. Asbun HJ, Rossi RL, Lowell JA, Munson L (1993) Bile duct injuryduring laparoscopic cholecystectomy: mechanism of injury, preven-tion and management. World J Surg 17: 547–552

2. Berci G, Sackier JM, Paz-Partlow M (1991) Routine or selected in-traoperative cholangiography during laparoscopic cholecystectomy.Am J Surg 161: 355–360

3. Bezzi M, Silecchia G, Orsi F, Materia A, Salvatori FM, Fiocca F,Fantini A, Basso N, Rossi P (1995) Complications after laparoscopiccholecystectomy. Coordinated radiologic, endoscopic and surgicaltreatments. Surg Endosc 9: 29–36

4. Brooks DC, Becker JM, Connors PJ, Carr-Locke DL (1993) Manage-ment of bile leaks following cholecystectomy. Surg Endosc 7: 292–295

5. Cox MR, Wilson TG, Jeans PL, Padbury RTA, Toouli J (1994) Mini-mizing the risk of bile duct injury at laparoscopic cholecystectomy.World J Surg 18: 422–427

6. Dubois F, Berthelot G, Levard H (1995) Coelioscopic cholecystecto-my: experience with 2006 cases. World J Surg 19: 748–752

7. Ezer P, Antal A, Schmidt P, Gula´csi I, Pavlovics G, Korompai F(1995) A laparoszko´pos cholecystectomia (LC) sora´n bekovetkezoepeutserulesek megelo¨zesenek leheto¨segei (The possible prevention ofbiliary tract injuries during laparoscopic cholecystectomy). Magy Seb48: 369–376

8. Faust H, Ladwig, D, Reichel K (1994) Die laparoskopische Cholecys-tektomie als Standardeingriff bei symptomatischen Cholecystolithia-sis. Erfahrungen bei 1277 Patienten. Chirurg 65: 194–199

9. Go PMNYH, Schol F, Gouma DJ (1993) Laparoscopic cholecystec-tomy in the Netherlands. Br J Surg 80: 1180–1183

10. Ihasz M, Rego¨ly-Merei J, Fazekas T, Ba´torfi J, Balint A, Zaborszky A,Posfai G (1995) Hazai tapasztalatok a laparoszko´pos cholecystectomiaszovodmenyeirol: 71 intezetben ve´gzett 13.833 mu¨tet elemzese (Ournational experiences with complications of laparoscopic cholecystec-tomy. Evaluation of 13,883 procedures in 71 institutes). Magy Seb 48:1–22

11. Jatzko GR, Lisborg PH, Pertl AM, Stettner HM (1995) Multivariatecomparison of complications after laparoscopic cholecystectomy andopen cholecystectomy. Ann Surg 221: 381–386

12. Kozarek R, Gannan R, Baerg R, Wagonfeld J, Ball T (1992) Bile leakafter laparoscopic cholecystectomy. Diagnostic and therapeutic appli-cation of endoscopic retrograde cholangiopancreatography. Arch In-tern Med 152: 1040–1043

13. Lezoche E, Paganini AM (1995) Single-stage laparoscopic treatmentof gallstones and common bile duct stones in 120 unselected, con-secutive patients. Surg Endosc 9: 1070–1075

14. Peiper M, Emmermann A, Rogiers X, Bro¨lsch CE (1994) Stenosierungdes Ductus Choledochus durch Metall-Clips nach laparoskopischerCholecystektome. Chirurg 65: 217–220

15. Phillips EH, Caroll BJ, Pearlstein AR, Daykhovsky L, Fallas MJ(1993) Laparoscopic choledochoscopy and extraction of common bileduct stones. World J Surg 17: 22–28

16. Raute M, Podlech P, Aschke WJ, Manegold BC, Trede M, Chiri B(1993) Management of bile duct injuries and strictures following cho-lecystectomy. World J Surg 17: 553–562

17. Rego¨ly-Merei J, Ihasz M, Fazekas T, Za´borszky A, Batorfi J, Barta T,Bereczky M, Szeberin Z (1995) A sonographia szerepe a laparoscoposcholecystectomia´ban (The role of sonography in the laparoscopic cho-lecystectomy). Orv Hetil 136: 1371–1379

18. Rieger R, Salzbacher H, Woisetschla¨ger R, Schrenk P, Wayand W

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(1994) Selective use of ERCP in patients undergoing laparoscopiccholecystectomy. World J Surg 18: 900–905

19. Rossi RL, Schirmer WJ, Braasch JW, Sanders LB, Munson JL (1992)Laparoscopic bile duct injuries. Risk factors, recognition and repair.Arch Surg 127: 596–602

20. Schol FBG, Go PMNYH, Gouma DJ (1995) Outcome of 49 repairs ofbile duct injuries after laparoscopic cholecystectomy. World J Surg 19:753–757

21. Schrenk P, Woisetschla¨ger R, Wayand WU (1995) Laparoscopic cho-lecystectomy: cause of conversions in 1300 patients and analysis ofrisk factors. Surg Endosc 9: 25–28

22. Stahlschmidt M, Lotz GW, Moergel K, Maurer T (1992) Ergebnisseder konventionellen und laparoskopischen Cholecystektomie. Z Gas-troenterol 30: 713–716

23. Stewart L, Way LW (1995) Bile duct injuries during laparoscopiccholecystectomy. Factors that influence the results of treatment. ArchSurg 130: 1123–1129

24. Traverso LW, Kozarek RA, Ball TJ, Brandabur JJ, Hunter JA, Jolly

PC, Patterson DJ, Ryan JA, Thirlby RC, Wechter DG (1993) Endo-scopic retrograde cholangiopancreatography after laparoscopic chole-cystectomy. Am J Surg 165: 581–586

25. van Sonnenberg E, D’Agostino HB, Easter DW, Sanchez RB, Chris-tensen RA, Kerlan RK Jr, Moossa AR (1993) Complication of lapa-roscopic cholecystectomy: coordinated radiologic and surgical man-agement in 21 patients. Radiology 188: 399–404

26. Wayand WU, Woisetschla¨ger R, Gitter T (1993) LaparoskopischeCholecystektomie in O¨ sterreich. O¨ sterreichisches Register in 1991.Chirurg 64: 303–306

27. Woods MS, Shellito JL, Santoscoy GS, Hagan RC, Kilgore WR, Tra-verso LW, Kozarek RA, Brandabur JJ (1994) Cystic duct leaks inlaparoscopic cholecystectomy. Am J Surg 168: 560–563

28. Woods MS, Traverso LW, Kozarek RA, Donohue JH, Fletcher DR,Hunter JG, Oddsottir M, Rossi RL, Tsao J, Windsor J (1995) Biliarytract complications of laparoscopic cholecystectomy are detected morefrequently with routine intraoperative cholangiography. Surg Endosc9: 1076–1080

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Editorial

Complications of laparoscopic cholecystectomy

There are several interesting articles in this issue, which callfor some comment.

In the multicenter study from Hungary by Rego¨ly-Mereiet al. [3], in 4 years 26,440 laparoscopic cholecystectomies(LCs) were reported and the information was obtained viaquestionnaires. In the same time period, more than 27,000additional gallbladders were removed in a standard openway. I cannot explain why LC did not gain wider acceptance(the operators inertia?, the economy?, special local circum-stances?). There are gigabites of data available with an enor-mous variety of statistical approaches, but there are someinteresting statements: “There was no significant correlationfound between the percentage of biliary tract injuries andthe absolute number of LCs performed in the same institu-tions . . .” Theauthors stated at a later stage that the inci-dence of complications decreased with experience. Thesampling range was enormous. If my interpretation is cor-rect, 21 institutions in the 4-year period performed 50 LCs(11⁄2 per year) and in 29 other hospitals, fewer than 300 LC(75 cases per year) were performed. In another 29 hospitals,more than 300 LCs were performed. Three hospitals hadmore than 1,000 LC and two hospitals performed more than2,000 LC procedures in the same 4-year time period.

I do not know how these large fluctuations of cases perhospitals could be brought to a common denominator if itcomes to analysis.

Only 34.5% of the injuries were discovered during thefirst operation, whereas more than two-thirds were seen inan average of 6–7 postoperative days. The total number ofductal injuries was 148. The bottom line of the article is the0.6% incidence of biliary tract injuries, which is higher, inmy opinion, than in the pre-LC era, even in Hungary. Thetype of injuries were: complete transections, 20.3%; partialinjuries, 35.1%; cystic duct lesion, 26.4%; excision of theduct: 6.8%.

The rest of the injuries were minor. The cystic “ductlesion” is not clearly described. Are we talking about aslippage of a clip? The rate of reoperation was 60.8% andthe dominant repair was suturing of the bile duct over aT-tube (42% of cases). Whether this technique of repair isoptimal can be addressed only if longer and accurate follow-up data are available.

The various contributors were blaming “identificationdifficulties” in 43.2% and problems in verifying the cysticduct common bile duct junction. The conversion rate, be-cause of visible bile leak (drain) was 63.9%. The averageperformance of a cholangiogram was only 6.9%, which is

low. The authors recommend further prospective studies “todetermine the ideal surgical technique to decrease the inci-dence of injuries and the best primary reconstructive proto-cols.” Before commenting on this huge number of data andevaluation of 26,000 + LCs, I would like to mention theother article.

Carroll et al. [1] in this same issue reported on commonbile duct injuries during laparoscopic cholecystectomy thatresulted in litigation. The reason I would like to discussthese two articles together is because they contain manysimilar problems.

In Carroll’s report, the authors analyzed 46 ductal inju-ries that resulted in litigation. Fifteen were transections, butonly 20% of the injuries were discovered during the primaryoperation. The average delay in diagnosis was ten days.These complications occurred whether the operation wasperformed by inexperienced or experienced laparoscopicsurgeons, but these particular data are incomplete. Thestatement of decreasing injuries with the learning curve ex-perience can be questioned. Four injuries occurred between50–100 cases and five after experiencing over 100 cases. Itis not uncommon that the learning period or learning curveexplanation is debated. In the references 78,000 cases witha bile duct injury of 0.36 to 0.47% were quoted.

In 16 of these 46 cases, cholangiograms were per-formed, but in 11 cholangiograms, the hold up of contrastmaterial was obvious, but the surgeon misinterpreted (over-looked) the findings. The settlement cost varied from$30,000 to $1.3 million with an average of $221,000.

The following questions arose while reading these twoarticles:

Ethical issues

It is true that ductal injuries will always occur if we operateon the biliary system and we will probably never achieve a0% incidence. However, all attempts should be made todecrease ductal injuries to a minimum. What should welearn from the last nine years to change our way of thinkingor to make changes in practicing biliary surgery if it comesto LC? The first message is an ethical one. Are we inform-ing the patient appropriately? There is no doubt that theincidence of ductal injuries was increased (by two to threetimes) since LC was introduced. Are we telling the patientthat there will be less postoperative discomfort, shorter hos-pitalization stay, faster return to activities, but there is a

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(slim) possibility that a significant complication with severesequelae could occur more frequently as compared with anopen operation? After an honest explanation of the pros andcons, should we not ask the patient about his or her choice?Patients are entitled to know that LC could have a highercomplication rate, particularly with regard to ductal injuries.

Intraoperative cholangiography

Intraoperative cholangiography has been debated since Mi-rizzi described it in 1933. I do not intend to go into endlesspro and cons, but LC has changed the indications as well asthe usefulness and importance of cholangiography. I under-stood the reluctance of the inpatient surgeons to wait 15–20minutes to receive the two or three films when a largepercentage is noninformative or technically unacceptable.

1. We embrace modern “high technology” quickly in work-ing from a TV screen with a new remote surgical tech-nique instead of the open exploration and naked eyevision. Approximately 30% of abdominal surgery is per-formed today with laparoscopy. We have difficulties inaccepting that there are digitized fluoroscopes availablein which one does not extend the operating time morethan 5–10 minutes because the image is immediatelyvisible. The digitized system improved the quality of thedisplay (information) significantly. I cannot underscorethe value (in 10% of cases) of discovering anomalies ofsurgical importance in a timely fashion. A good exampleis the short cystic duct. If this is not recognized, thenormal caliber CBD is pulled laterally and is thereforetented. This can mislead the operator to misinterpret theso-called “cystic duct,” which is really a CBD, whichwill be double-clipped and transected. This appearancecan be discovered immediately with fluorocholangiogra-phy (cholangio grasper proximity to the main duct). In2% of cases, the short cystic duct can drain into the righthepatic duct or a spiral cystic duct crosses very near thecommon hepatic duct. Injuries can be avoided if atten-tion is drawn in time to dangerous anomalies at the pri-mary operation.

2. The problems are enhanced if the case is difficult or is anacute one where efforts made to clarify the anatomy inthese cases are time-consuming. A cystic duct or chole-cysto-cholangiogram could be of great help in identify-ing the structures. The cholangiogram will give yousome hints. If you extend the operating room time only10 minutes, the effort is worthwhile. Do not hesitate toconvert—and still perform a cholangiogram.

3. If the injury is discovered by reading the films properly,this should indicate the need for immediate exploration.Surgeons who cannot read gross changes on a cholan-giogram (for instance stop of contrast material or extrav-asation) should not operate on the biliary system. Thepatient is much better off if immediately operated uponthan to be re-explored a few days later, attempting thento repair the injury in an abdomen with biliary peritoni-tis.

4. A large number or the majority of preoperative of ERCPscan be avoided if routine fluorocholangiography is em-

ployed. This endoscopic procedure has a morbidity, andentails a significant additional cost. There is only oneindication for a preoperative ERC: the high-risk patientwith a severe comorbid condition (septicemia, cholangi-tis, or jaundice), where ERC should be the first step.

5. The majority of surgeons abrogated the removal of CBDstones and refer it to the endoscopist for a second pro-cedure with additional morbidity and mortality, notspeaking about the cost. There is no excuse for a surgeonnot acquiring the additional skill or the equipment. Cho-ledocholithiasis is a surgical disease. If performed lapa-roscopically, fluorocholangraphy is obligatory, but thisis a separate story.

6. There are also some lessons to be learned from the ar-ticles about the postoperative period. Only 10–20% ofinjuries are discovered during the primary operation. Themajority are operated late because of severe symptoms(peritonitis, jaundice, etc.). Stricture formation can occurlater (6–24–48 months) after the primary operation. Thelesson is that if the patient on the first postoperative dayhas only vague symptoms, for instance, did not want toget out of bed in the morning, does not eat breakfast,does not feel 100%, this may indicate injury. Some rou-tine laboratory examinations can be noninformative. Thesurgeon should immediately think of the possibility ortry to exclude the presence of bile leak by ordering aHida scan, and if positive, follow this with an emergentERCP and immediate operation.

If a normal caliber duct is transected or an injury foundin an infected abdomen, the surgeon should secure a tube inthe proximal lumen of the transected duct and drain the bilein a container outside. Drain also the abdominal cavity. Thesurgeon wins time and can perform the repair under betterconditions at a later stage—if the surgeon feels competent todo this special procedure—or he or she can refer the case toa tertiary center.

Another article of interest is one by Scha¨fer et al. [4],who made a retrospective analysis of 10,000 LCs withspilled stones. In 5.7%, this problem was discovered. Itseems that in other studies it occurred more frequently. Thecomplications of these events are abscess formation or, at alater stage, fistula formation. Therefore, all attempts shouldbe made to recover spilled stones. Place the gallbladder in abag during the pull-through maneuver, which could be an-other source. The authors discuss the indication for conver-sion, which should be considered if (large) or innumerablecalculi are lost and are difficult to retrieve. The formation ofabscesses in the author’s experience was low (0.08%), butcan occur. Again the patient should be informed of thisevent and the problem should be explained to draw attentionto it. If early symptoms should occur, the patient shouldimmediately report this to the surgeon. There is no questionthat the recommendation to retrieve all stones—if pos-sible—is advisable.

Dr. Marks et al. [2] reported an experimental study ofthe advantages of biliary stenting in cystic duct leakagewithout sphincterotomy. This study was performed in dogsand showed that those groups without sphincterotomy butonly stented fared better than the group with sphincteroto-my. Cystic stump leakage is unfortunately common after

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LC and stenting alone (with less mobidity), which woulddecrease the resistance of the sphincter, facilitating free bileflow, and which would be sufficient prevention. Spontane-ous closure of the cystic stump will occur.

We should be aware that minimal access surgerycan sometimes carry a maximal risk. We should know it;the patient should know it. Every attempt should be madeto decrease this dreadful complication, avoiding thecreation of biliary cripples by educating ourselves, devel-oping better judgment, and having a more open mind forthe use of routine fluorocholangiography and early converi-son.

Recommended reading

Berci G, Cuschieri A (1997) Bile ducts and ductal stones.Saunders, Philadelphia

References

1. Carroll BJ, Birth M, Phillips EH (1998) Common bile duct injuriesduring laparoscopic cholecystectomy that result in litigation. Surg En-dosc 12: 310–314

2. Marks JM, Ponsky JL, Shillingstad RB, Singh J (1998) Biliary stentingis more effective than sphincterotomy in the resolution of biliary leaks.Surg Endosc 12: 327–330

3. Regoly-Merei J, Ihasz M, Szeberin Z, Sa´ndor J, Mate M (1998) Biliarytract complications in laparoscopic cholecystectomy: a multicenterstudy of 148 biliary tract injuries in 26,440 operations. Surg Endosc 12:294–300

4. Scha¨fer M, Suter C, Klaiber Ch, Wehrli H, Frei E, Kra¨henbuhl L (1998)Spilled gallstones after laparoscopic cholecystectomy: a relevant prob-lem? A retrospective analysis of 10,174 laparoscopic cholecystecto-mies. Surg Endosc 12: 305–309

George Berci

Cedars-Sinai Medical CenterLos Angeles, CA 90048, USA

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Bilateral thoracoscopic stapled volume reduction for bullous vsdiffuse emphysema

J. K. Champion, J. B. McKernan

Dunwoody Medical Center, 4575 North Shallowford Road, Atlanta, GA 30338, USA

Received: 14 May 1997/Accepted: 6 August 1997

AbstractBackground:We compared our results with bullous vs dif-fuse emphysema by performing a bilateral thoracoscopicstapled volume reduction technique in 15 patients (age 45–80, 10 males, five females).Methods:Eight patients demonstrated bullous emphysemaand seven patients diffuse emphysema. Lung reduction wasperformed with a bilateral thoracoscopic stapled techniqueutilizing bovine pericardium in the supine position.Results:Comparison of the bullous versus diffuse groupsrevealed no significant differences in means for the follow-ing variables: length of air leak (7.5 vs 3.3 days); length ofstay (8.1 vs 6.5 days); pre-op FEV1 (23% vs 22%); pre-opdyspnea index (3.4 vs 3.6). At 3 months the bullous subsethad a highly significant improvement (p < 0.007) in FEV1(88%) compared with the diffuse subset FEV1 (59%).Conclusions:These early results suggest that patients withbullous emphysema are at no greater risk and demonstrate asignificantly greater improvement in FEV1 than patientswith diffuse emphysema.

Key words: Thoracoscopic — Emphysema — Lung vol-ume reduction

Lung volume reduction (LVR) surgery for emphysema wasfirst reported by Brantigan in 1960 utilizing sequentialstaged open thoracotomies and suturing [2]. The associatedmortality (16%) reported with this technique discouraged itswidespread adoption despite the symptomatic improvementreported by the majority of survivors. The modern era oflung volume reduction began with the report of Cooper andassociates in 1992 when they described their results em-

ploying a simultaneous stapled technique via a median ster-notomy [4]. By surgically reducing the hyperinflated lungvolume associated with advanced chronic obstructive pul-monary disease (COPD), significant improvement in pa-tients’ pulmonary function and quality of life has been dem-onstrated [4, 5]. Advances in videoscopic instrumentationand technology allowed a thoracoscopic approach to be em-ployed by a number of surgeons with outcomes equivalentto the open technique [1, 6, 7, 9, 10, 12]. Patient selectioncriteria vary, however, and several centers exclude patientswith bullae greater than 5 cm [1, 7, 10, 11]. It has beenstated that patients with bullous disease develop severe airleaks which prolong hospitalization and lead to an unsuc-cessful result. In this study, we compared our results inperforming a bilateral thoracoscopic stapled volume reduc-tion in patients with diffuse vs bullous emphysema to de-termine whether multiple bullae greater than 5 cm. shouldexclude patients as candidates for surgery.

Materials and methods

Patient population

From November 1995 through April 1996, 15 patients underwent bilateralthoracoscopic stapled volume reduction. There were 10 males and fivefemales, ages 45–80. All patients had end-stage emphysema with signifi-cant functional impairment due to dyspnea and had been on maximalmedical management. Supplemental oxygen, at rest, was required by 53%.Steroids were used by 40% of candidates. Preoperative evaluation con-sisted of pulmonary function tests, arterial blood gas, chest X-ray withcomputed tomography (CT), selected ventilation-perfusion (V/Q) scans,and evaluation of dyspnea index by Modified Medical Research CouncilDyspnea Scale [14]. Eight patients demonstrated multiple bullae greaterthan 5 cm without compression of surrounding emphysematous lung onCT and were classified as having bullous emphysema. Seven patientsexhibited diffuse emphysema alone. Diffuse emphysema was defined asgeneralized parenchymal destruction with no distinct bullae. Eligible pa-tients demonstrated hyperinflation with a heterogeneous pattern of paren-chymal involvement on radiologic evaluation. Eligibility criteria are listedin Table 1.

Operative technique

Patients were admitted the morning of surgery. A double-lumen endotra-cheal tube and general anesthesia were employed to allow isolated venti-

Presented at the annual meeting of the Society of American Gastrointes-tinal Endoscopic Surgeons (SAGES), San Diego, California, USA, 20–21March 1997Correspondence to:J. K. Champion, 130 Vann Street Suite 220, Marietta,GA 30060, USA

Surg Endosc (1998) 12: 338–341

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lation to either lung. A flexible bronchoscopy is routinely performed to ruleout an occult intrabronchial malignancy and to confirm proper positioningof the double-lumen endotracheal tube. Patients were placed in the supineposition, which in our experience is better tolerated hemodynamically thana lateral decubitus position and reduces operating time since both thoracesare accessible without repositioning and redraping. An initial thorax ischosen to begin, and the lung was deflated with one-lung ventilation to thecontralateral thorax. A three-port videoscopic technique was employed toaccess each pleural space. The pleural space was initially entered in theanterior axillary line at the level of the nipple with a 12-mm Optiviewtrocar (Ethicon Endosurgery, Cincinnati, Ohio) and 10-mm 0° videoscope.This allows direct visualization as the pleura is entered to avoid adhesionsand prevent inadvertent lung injury which can increase air leaks. After thepleural space was entered, inspection identified the most diseased areas oflung as they remained hyperinflated, while more normal areas collapsedfrom absorptive atecletasis. Insufflation to 5 mm was begun to aid in morerapid collapse of the lung and was then discontinued. No adverse hemo-dynamic effects have been noted with insufflation. Two 5-mm ports werethen inserted in the anterior midclavicular line in the second and sixthinterspaces. The 10-mm 0° videoscope was then exchanged for a 5-mm 30°videoscope which was inserted in the lower anterior port. The optical trocarwas removed and a 20-mm flexible Thoracoport (Ethicon Endosurgery,Cincinnati, Ohio) was reinserted at the same lateral site. Utilizing the CTscan and visual inspection, we identified the area for planned resection,attempting to remove 20–30% of the lung volume of each lung. A 45-mmthoracoscopic stapler (Ethicon Endosurgery, Cincinnati, Ohio) with bovinepericardial strips was then utilized to perform the excision-plication alonga linear continuous line. An area approximately 5 cm × 15 cm was re-moved, which usually requires five stapler firings per side. The excisedtissue was removed via the Thoracoport and examined pathologically. Thevideoscope was transferred to the upper 5-mm anterior port and a single24-Fr straight chest tube was inserted via the lower 5-mm port and posi-tioned at the apex of the chest. The lung was inflated under direct visual-ization and inspected for air leaks, and the chest tube was connected to anunderwater seal. Suction of −10 cmH2O is utilized only for massive SQemphysema or for a pneumothorax greater than 30%. The same procedureis then repeated on the contralateral lung. Operative time averaged 90 min.

All patients were extubated in the operating room and none requiredmechanical ventilation. Patients were monitored in ICU for 24–72 untilhemodynamically stable. Physical therapy and ambulation, twice daily,were begun on postop day 1. The chest tube was connected to a Heimlichvalve for prolonged air leaks (>5 days). Intensive chest physiotherapy wasutilized and perioperative antibiotics were given for 3–5 days. Pain man-agement was by either thoracic epidural analgesia or by Patient-ControlledAnesthesia (PCA)—intravenous narcotics by patient choice for the first 72h, then converted to oral medications.

Statistical analysis

Student’s pairedt-tests were used to evaluate changes between groups inpulmonary function, length of stay, and length of air leak. Wilcoxonmatched-pairs signed rank test was utilized to examine differences in dys-pnea index between groups. Ap value of less than 0.05 was consideredsignificant.

Results

There were no operative deaths. Complications are listed inTable 2. The major postop complication was a prolonged air

leak over 7 days in duration. Upon discharge, patients wereinstructed on a home exercise program without formal pul-monary rehabilitation. At 3 months postoperatively all pa-tients underwent reevaluation with pulmonary function testsand assessment of dyspnea index.

Preoperative pulmonary function tests and dyspnea in-dex are listed in Table 3 along with in-hospital variables oflength of air leak, number of stapling firings, and length ofstay. Comparison of the means for the bullous vs diffusegroups revealed no significant differences.

Postoperative evaluation at 3 months revealed a highlysignificant improvement in pulmonary function and dys-pnea index for both groups (Table 4). However, the bulloussubset had a highly significant (p < 0.007) improvement inFEV1 compared with the diffuse subset.

Discussion

As early results of lung volume reduction surgery werereported, questions arose as how to best define the limits forthe procedure [13]. The primary areas of controversy in-clude: (1) What is the extent of preoperative evaluation? (2)What parameters should be used to identify who is a can-didate? (3) What surgical approach should be used? (4)What is the role of pulmonary rehabilitation? Our approachhas been to simplify the evaluation and attempt to refine thetechnique so that it may be offered to the greatest number ofpatients who may benefit, and to provide this in a commu-nity setting.

The extent of preoperative evaluation is important toproperly identify those patients who may benefit from lungreduction surgery, but excessive testing could result in anunnecessary socioeconomic burden due to the large numberof potential candidates eligible to be screened. Our approachhas been to simplify the preoperative evaluation by rou-tinely performing only pulmonary function tests, arterialblood gases, and chest X-ray with computed tomography.Ventilation-perfusion lung scans were utilized only in se-lected patients with diffuse emphysema to identify targetareas for resection. Two diffuse emphysema patients had apattern on CT scan that was ambiguous; therefore, a V/Qscan confirmed a heterogenous pattern suitable for resec-tion. In patients with bullous emphysema, the CT scan wassufficient to direct the resection. A cardiac evaluation wasobtained only if a history of unstable heart disease waspresent.

There appears to be general agreement among reportedseries on the selection criteria listed in Table 1 [1, 5–7, 9,12]. We disagreed, however, that patients with multiple bul-lae >5 cm without compression of underlying lung shouldbe excluded from consideration [1, 7, 10, 11]. It has beenestablished that patients with giant bullae that occupy over

Table 1. Eligibility criteria for thoracoscopic stapled volume reduction

l Chest X-ray with hyperinflationl Heterogeneous pattern on chest CT or V/Q scanl Forced expiratory volume in 1 s (FEV1) <35%l Total lung capacity (TLC) >125%1

l Respiratory volume (RV) >250%l Nonsmokerl pCO2 < 65 mml Marked impairment in physical activity despite maximal medical man-

agementl No pulmonary hypertension >35 mm Meanl No major coexisting medical problems

Table 2. Complications of thoracoscopic stapled volume reduction

Complication No. of patients (%)

Air leak over 7 days 4 (27)Arrhythmia 1 (6)Panic attack 1 (6)Urinary retention 8 (54)

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30% of a thorax and compress underlying lung tissue canbenefit from resection [3, 8]. Our previous experience inthoracoscopically resecting bullae in emphysema patientsafter a spontaneous pneumothorax was encouraging, as pa-tients reported subjective symptomatic improvement in pre-op dyspnea. We therefore included a bullous subgroup inour study, anticipating they might experience a higher inci-dence of air leak and length of stay. Our data indicated bothgroups postop had a highly significant improvement inFEV1 and dyspnea index. It was surprising, however, to seethat the bullous group improvement (88%) was highlysignificant (p < 0.007) compared to the diffuse group (59%).Resecting 20–30% of volume occupying bullae may,theoretically, remove proportionally less pulmonary paren-chyma than the same resection in diffuse emphysema.Indeed, our diffuse groups [2] 59% improvement in FEV1compares with Cooper’s 51% after median sternotomy[4, 5].

Our data further demonstrated that there was no signifi-cant difference in length of air leak, number of stapler fir-ings, or length of hospital stay between the two groups. Ourincidence of prolonged air leaks (27%) was approximatelyhalf of the incidence (46%) reported by Cooper [5]. Wecould not attribute any increase in air leaks in our study tothe type emphysema or to steroid usage. There were twoprolonged air leaks in both the diffuse and bullous sub-groups. While 40% (two bullous, four diffuse) of our pa-tients utilized steroids, only one prolonged air leak (diffusepatient) occurred in the steroid users, for an overall inci-dence of 17% (1/6). Indeed, the 30% prolonged air leak ratewas higher in our nonsteroid group (3/9).

A variety of surgical approaches have been advocated.Controversy exists as to whether an open or thoracoscopicincision is better and as to whether a unilateral, bilateralsimultaneous, or bilateral staged procedure offers advan-tages. Our approach was to adopt a bilateral simultaneousthoracoscopic approach in the supine position, which webelieve is less traumatic and therefore better tolerated. The

goal of removing 20–30% of each lung by a stapled bovinepericardial technique can be accomplished thoracoscopi-cally today. We believe the videoscopic technique we uti-lized involves less handling and manipulation of the lung,which may allow for reduced air leaks. We adopted a bi-lateral simultaneous approach with the philosophy of at-tempting to improve the patients as much as possible withone procedure. McKenna and associates found their resultswith a bilateral thoracoscopic approach were comparable tomedian sternotomy and had no increased mortality or mor-bidity [9]. Economically, the savings favor a single bilateralprocedure over two separate admissions. The quality of im-provement in patients’ pulmonary function with a bilateralvolume reduction (57%) vs a unilateral (31%) is significant.The recovery from just one procedure allows patients tomaximize recovery in a shorter time than staged proceduresperformed on separate dates, with the overall goal of lungreduction surgery to improve the patient’s quality of life.

We omit a formal pulmonary rehabilitation program,which is one area of controversy in our approach to lungvolume reduction surgery. Some authors exclude any pa-tient from consideration unless they can complete pulmo-nary rehabilitation and perform 30 min of sustained exerciseon a treadmill or bike [11]. We felt this requirement wouldrestrict access to a potentially therapeutic modality and se-lect out only the most physically fit patient, who it can beargued is least in need of the procedure. We utilized nopulmonary rehabilitation preoperatively but insisted onearly ambulation and exercise postoperatively. The patientswere instructed in the importance of exercise and givengoals for twice-daily exercise at home. This was monitoredas an outpatient and gradually increased to a goal of 30 minsustained exercise within 3 months of discharge. Our pa-tients experienced no mortality or ventilatory support, andour functional results with improvement in FEV1 and dys-pnea index appear comparable with other studies which uti-lized rehab [1, 7, 10, 11]. We believe postop exercise isimportant for good functional results but may be accom-plished economically at home with proper instruction.

Finally, all of our procedures were performed in a com-munity hospital rather than academic teaching institutions.Our hospital charges averaged $30,000 compared with the$50,000 reported by some centers [13].

Ultimately, questions regarding surgical approach, roleof pulmonary rehabilitation, and further refining of selec-tion criteria may be clarified in the future with pendingrandomized prospective studies proposed by Medicare.

This report demonstrates that for a bilateral thoraco-scopic stapled volume reduction, patients with bullous em-physema are at no greater risk and demonstrate a signifi-cantly greater improvement in pulmonary function than pa-tients with diffuse emphysema.

References

1. Bingisser R, Zollinger A, Hauser M, Bloch K, Erich R, Weder WBilateral volume reduction for diffuse emphysema by video assistedthoracoscopy. J Thorac Cardiovasc Surg 112: 875–882

2. Brantigan OC, Kress MB, Mueller EA (1961) The surgical approach topulmonary emphysema. Dis Chest 39: 485–501

3. Connolly JE, Wilson AF (1989) The current status of surgery forbullous emphysema. J Thorac Cardiovasc Surg 97: 351–361

Table 3. Comparison of preoperative and in-hospital variables betweengroups

Bullous Diffuse

Stapler firings 11 9.7Length of air leak 7.5 days (range:

1–35 days)3.3 days (range:

1–9 days)Length of stay 8.1 days (range:

3–13 days)6.5 days (range:

3–10 days)Pre-op FEV1 volume 673 cc 585 ccPre-op FEV1 percent 23% (range: 14–30%) 22% (range:

13–32%)Pre-op dyspnea index 3.4 3.6

Table 4. Comparison of postoperative pulmonary function and dyspneaindex

Bullous Diffuse

Post-op FEV1 volume 1,265 cc 930 ccPost-op FEV1 44% (88%

improvement)35% (59%

improvement)Post-op dyspnea index 1.3 1.4

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4. Cooper JD, Trulock EP, Triantafillou AN, Patterson GA, Pohl MS,Deloney PA, Sundaresan RS, Roper CL (1995) Bilateral pneumectomy(volume reduction) for chronic obstructive pulmonary disease. J Tho-rac Cardiovasc Surg 109: 106–119

5. Cooper JD, Patterson GA, Sundaresan RS, Trulock EP, Yusen RD,Pohl MS, Lefrak SS (1996) Results of 150 consecutive bilateral lungvolume reduction procedures in patients with severe emphysema. JThorac Cardiovasc Surg 112: 1319–1330

6. Eugene J, Ott RA, Gogia HS, et al. (1995) Video-thoracic surgery fortreatment of endstage bullous emphysema and chronic obstructive pul-monary disease. Am Surg 61: 933–936

7. Keenan RJ, Landreneau RJ, Sciurba FC, Ferson PF, Holbert JM,Brown ML, Fetterman LS, Bowers CM (1996) Unilateral thoraco-scopic surgical approach for diffuse emphysema. J Thorac CardiovascSurg 111: 308–315

8. Laros CD, Gelissen HJ, Bergstein PG (1986) Bullectomy for giantbullae in emphysema. J Thorac Cardiovasc Surg 35: 480–487

9. McKenna RJ, Brenner M, Fischel RJ, Gelb AF (1996) Should lungvolume reduction for emphysema be unilateral or bilateral. J ThoracCardiovasc Surg 112: 1131–1339

10. McKenna RJ, Brenner M, Gelb AF, Mullin M, Singh N, Peters H,Panzera J, Calmese J, Schein MJ (1996) A randomized prospectivetrial of stapled lung reduction versus laser bullectomy for diffuse em-physema. J Thorac Cardiovasc Surg 111: 317–322

11. Miller JJ, Lee RB, Mansoor KA (1996) Lung volume reduction sur-gery: lessons learned. Ann Thorac Surg 61: 1464–1469

12. Naunheim KS, Keller CA, Krucylak PE, Singh A, Ruppel G, OsterlohJF (1996) Unilateral video assisted thoracic surgical lung reduction.Ann Thorac Surg 61: 1092–1098

13. Rusch VW (1996) Lung reduction surgery: a true advance? J ThoracCardiovasc Surg 111: 293–295

14. Task Group on Screening for Respiratory Disease in OccupationalSettings (1982) Official statement of the American thoracic society.Am Rev Respir Dis 126: 952–956

Discussion

Dr. Greene: In my discussion with individuals doing thisprocedure, the real commitment is ICU care and the costinvolved. These patients can really take over your entire unitif you’re not careful. Could you comment on the length ofICU management in this population of patients?

Dr. Champion:Our routine is to place the patients in theICU at least overnight. The average stay is usually one tothree days. We looked at our cost for a procedure. For thesefirst 15 patients we averaged $29,000 for the hospitaliza-tion, compared to $55,000 involved with an open ster-notomy. Certainly postoperatively, because of the changesin V/Q shunt, there’s a real roller-coaster for the first 72hours as the body is adjusting. The pO2s run anywherefrom 40% up to 90%, and part of this is just training thenursing staff to allow the patients to adjust and not to over-react. We basically just ignore the pO2 postop.

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How, when, and why bile duct injury occurs

A comparison between open and laparoscopic cholecystectomy

E. M. Targarona,1,3 C. Marco,2 C. Balague,1 J. Rodriguez,2 E. Cugat,2 C. Hoyuela,2 E. Veloso,1 M. Trias 1,3

1 Service of Surgery, Hospital Clinic, Villarroel 170, 08036 Barcelona, Spain2 Service of Surgery, Hospital de Mutua de Terrassa, García Humet 2, Terrassa, University of Barcelona, Barcelona, Spain3 Service of Surgery, Hospital de S. Pau. Avda. P. Claret 167, 08025 Barcelona, Spain

Received: 6 June 1997/Accepted: 8 September 1997

AbstractBackground:Bile duct injury (BDI) is a severe complica-tion of laparoscopic cholecystectomy (LC). There is generalagreement about the increase of this complication after LCvs open cholecystectomy (OC), but comparative studies arescarce. The aim of this paper has been to compare the in-cidence and clinical features of BDI after LC vs open pro-cedures.Materials and methods:3,051 OC, performed from June1977 to December 1988 were retrospectively analyzed andcompared with 1,630 LCs performed from June 91 to Au-gust 96, for which data were prospectively recorded. Age,sex, type of BDI, performance of intraoperative cholangi-ography (IOC), underlying biliary pathology, morbidity,mortality, and late morbidity were all analyzed.Results:BDI incidence was higher in group II (LC) (N: 16,0.95%) than in group I, (OC,N: 19, 0.6%). BDI incidencewas also higher in the group of patients in which it wasnecessary to convert to an open procedure (3/109, 2.7%,p< 0.05). BDIs were more frequently diagnosed intraopera-tively in group I (OC, 18/19) than in group II (LC, 12/16).In both groups, BDI was more prevalent in cases operatedby staff surgeons than residents, mainly in complicated gall-bladder patients, with a bile duct of less than 7-mm diam-eter. Morbidity, postoperative stay, mortality, and late mor-bidity were similar after a BDI in both types of approach.Conclusion:(1) BDI increases with LC. (2) BDI after LCcarries a similar postoperative morbidity and mortality tothose after OC. (3) Incidence of BDI in converted casesincreases significantly and this constitutes a high-riskgroup.

Key words: Gallstones — Open cholecystectomy — Lap-aroscopic cholecystectomy — Bile duct injury

Because of the benign nature of biliary surgery for gall-stones, it should be followed by minimal morbidity andmortality. With the developmen of laparoscopic cholecys-tectomy (LC), a smooth and quick recovery is added. How-ever, severe complications can occur and bile duct injury(BDI) is devastating after cholecystectomy. Soon after re-ports of early series of laparoscopic cholecystectomy, sev-eral authors commented on the quick rise in the incidence ofsevere BDI [6, 8, 11, 15] (Table 1). The special character-istics of laparoscopic surgery and the modifications of thestandard surgical rules used for years in biliary surgery (rou-tine colangiography or drainage, transcystic bile duct ex-ploration) have modified the incidence, mechanisms, andclinical features of BDI [2, 5, 10, 12, 17, 19, 20].

However, reports of BDI after LC are subject to manybiases. Complications tend to be underreported, especiallywhen a new technique is being developed. Early reportscome from personal experience or from specialized centers,which may downplay the real incidence in the general sur-gical community [2, 5, 9, 19]. Surveys frequently fail toreceive a sufficient number of answers, and they mainlycover severe cases [10, 20]. Few reports have tried to com-pare the incidence and features of BDI in open vs laparo-scopic surgery. In 1992 the present authors performed aretrospective analysis of the incidence of BDI in a series of3,051 cholecystectomies. The results of this series havebeen used as a reference for comparison with a prospectiveseries of 1,600 LCs performed in a similar setting [21, 22].

Materials and methods

Open operation

Some 3,051 open cholecystectomies performed between June 1977 andDecember 1989 in the Department of Surgery of the Hospital de Mutua deTerrassa were retrospectively analyzed. Intraoperative cholangiography(IOC) and subhepatic were routinely used.

All the reports of the operations were scanned for a description of anextrahepatic bile duct injury, defined as the partial or total involuntarysection of the duct with or without loss of substance. Rupture of the

Presented as a free paper at the Fifth Meeting of the E.A.E.S., Istanbul,Turkey, 17–21 June 1997

Correspondence to:E. M. Targarona

Surg Endosc (1998) 12: 322–326

© Springer-Verlag New York Inc. 1998

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gallbladder was not considered a BDI. Dehiscence after biliodigestiveanastomosis, postoperative pancreatitis, and biliary leak after T-tube re-moval were excluded. Results of this series have been published elsewhere[21, 22].

Laparoscopic cholecystectomy

This group included 1,670 laparoscopic cholecystectomies; 1,142 wereoperated on in the Hospital de Mutua de Terrassa between June 1991 andJune 1996. The other 528 patients underwent operations between January1992 and July 1996 in the Hospital Clinic of Barcelona and data was storedin a prospective database. Intraoperative cholangiography was performedselectively. Patients suspected of having bile duct stones received a pre-operative ERCP. No liver bed drainage was used routinely.

For analysis of the laparoscopy group, it was divided between patientswith completed LC and patients whose LC was converted to open surgery.

Gender, age, preoperative diagnosis, operative diagnosis, experience ofthe surgeon, technical difficulty encountered in the operative field, intra-operative cholangiography, diameter of the bile duct, anatomy of the biletree, early and late morbidity, and mortality were all recorded.

Definitions

BDI has been classified in two categories, depending of the tme of diag-nosis [10]: Group 1. BDI diagnosed during the surgical procedure: 1.a.Severe: This included transection of the bile duct or loss of substance ofmore than 25% of the circumference. 1.b. Mild: Longitudinal tears orpuntiform defects with a minor loss of substance. Group 2. BDI injurydiagnosed in the early postoperative period, usually as biliary leakage, bileperitonitis, or jaundice and cholangitis.

In order to analyze the impact of technical difficulty on BDI, the

operations were classified into three BDI risk categories. Risk I: Chole-cystectomy without inflammatory signs, Risk II: Cholecystectomy associ-ated to bile duct exploration. Risk III: Acute cholecystitis, scleroatrophicgallbladder, or when the surgeon stated the technical difficulty of identi-fying Calot’s triangle structures.

Results were analyzed using the chi2 test or Student’st-test.

Results

Open operation

During the study period, 3,051 cholecystectomies for gall-stones were performed. In 685 cases, a surgical explorationof the bile duct was added (23%). Intraoperative cholangi-ography was performed in 93.4% of patients. NineteenBDIs were found, an incidence of 0.6% (19/3,051). Meanage was 65 ± 17 years (29–84). Gender distribution wassimilar (eight males and 11 females) (Table 2).

Three BDIs occurred at the common bile duct and sevenat the hepatic duct. Three others occurred in the right he-patic duct, and one each in the left hepatic duct, bifurcation,and cystic and hepatic confluence. In 18 patients, the BDIwas diagnosed intraoperatively; and in one case, in the im-mediate postoperative period (high-output biliary fistula).Anomalous anatomy was not found in any case. In 12 out ofthe 19 cases, the diameter of the bile duct was under 10 mm.It is noteworthy that in six of seven patients with a severeBDI, the bile duct size was less than 7 mm. In 12 out of the19 patients (66%), IOC helped to find the BDI, but in the

Table 1. Incidence of BDI in cumulative series of laparoscopic cholecystectomies

McMahon [13] Strasberg [21]

n nBDI % Range n n BDI % Range

Open cholecystectomy 66,163 160 0.2 (0–0.5)Laparoscopic cholecystectomy

(single centre experiences (>300 cases)) 11,978 36 0.3 (0–1.8)Laparoscopic cholecystectomy

(multicentric series) 136,816 634 0.5 (0.1–0.9)Open cholecystectomy

(multicentric series and surveys) 25,544 81 0.32 (0–0.9)Laparoscopic cholecystectomy

(multicentric series and surveys) 124,433 650 0.52 (0–2.3)

Table 2. Comparative analysis of BDI between open and laparoscopic cholecystectomy

Laparoscopic

Open(n:3051)

Completed LC(n:1,561)

Converted LC(n:109 [6.5%])

Overall LC(n:1,670)

No. bile duct injuries 19 (0.6%) 13 (0.8%) 3 (2.7%) 16 (0.95%)Transection bile duct 6 (0.2%) 4 (0.24%) 1 (10.9%) 5 (0.29%)Age 65 ± 17 59 ± 14 72 ± 9 61 ± 14Sex (m/f) 8/11 5/8 2/1 7/9Diagnosis of BDI by intraoperative cholangiography 67% 40% — 33%Complicated clinical presentation of gallstones 70% 53% 66% 56%Diameter bile duct <7 mm 63% 77% 33% 68%Morbidity 50% 46% 33% 43%Mortality 5% 7.7% 33% 12%Postoperative stay (days) 25 ± 15 23 ± 26 28 ± 24 24 ± 25Late morbidity 35% 17% 50% 25%

BDI, bile duct injury; LC, laparoscopic cholecystectomy.

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others the clue was the appearance of bile in the operativefield.

Operative findings in this group were acute cholecystitisin ten, bile duct stones in two, atrophic gallbladder in one,and chronic cholecystitis in the other six.

BDI injury occurred more frequently in patients with acomplex intraoperative field than during a noninflammatorycholecystectomy (p < 0.05) (Table 3); and also when trainedsurgeons rather than surgical residents did the operations(16/2,051 [0.8%] vs 3/1,000 [0.2%],p: NS).

The mechanism of BDI and treatment are summarizedin Tables 4–6. Nine of the patients (50%) developed post-operative complications and one patient died after an he-paticojejunostomy. Fourteen of these patients were fol-lowed up for a mean of 33 months (5 months to 9 years).Five of them developed late complications (cholangitis[two], splenic abscess [one], bile duct stenosis [one], andcholedocholithiasis [two]). Two of them underwent a sec-ond operation for bile duct stones and a splenic abscess wasdrained percutaneously.

Laparoscopic surgery

Completed LC.Of the 1,670 LCs attempted, 1,561 weresuccessfully performed, with a conversion rate of 6.5% (109patients). IOC was performed on 426 (25%) of these pa-tients. Preoperative ERCP was performed on 334 (20%)patients suspected to harbor bile duct stones, and intraop-erative exploration of the bile duct (transcystic or choledo-chotomy) was done in 30 (1.7%) patients (Table 2).

Thirteen BDI injuries were identified (0.8%). Mean agewas 59 ± 14 years. Nine cases were diagnosed periopera-tively (69%). Five of them were severe BDI and four were

minor injuries. IOC as performed in 37% of these cases andhelped to the diagnosis of the BDI in two of five cases.Transection of the bile duct occurred in four cases and par-tial transection in one, in all of them when it was confusedwith the cystic duct. In one case, the hepatic duct was in-jured when dissecting Hartmann’s pouch; in two cases, theconfluence of cystic and hepatic duct was injured on at-tempting IOC. In a fourth case, the confluence of a short andparallel cystic duct that was inserted in the right hepatic ductwas injured with the clip applier when attempting IOC. Inall these cases, BDI was diagnosed intraoperatively: by IOCin two, by the presence of bile in the operative field, or bythe observation of the uncorrectly clipped structure in thehepatic hilum. Five of these patients were converted, andthe bile duct was repaired (three hepaticojejunostomies andtwo end-to-end reconstructions over a T tube). The otherfour cases were not converted, and were resolved with thelaparoscopic insertion of a T tube (Tables 4–6).

Four cases were diagnosed in the immediate postopera-tive period due to bile peritonitis and all of them werereoperated. In one case, an orifice in the hepatic bile ductwas observed, and in the other three, a dislodgement of aclip and an orifice near the clip in the cystic–hepatic junc-tion was identified. Two of them were treated with suturesover a T tube and two with ligature of the cystic stump.

In the group as a whole, preoperative and intraoperativediagnosis in eight of the patients with BDI were noncom-plicated gallbladders; meanwhile, complicated manifesta-tions of gallstones (acute biliary pancreatitis [PAB], acutecholecystitis, bile duct stones) appeared in the other eight(Table 3). In 77% of cases, the bile duct was below 7 mmin diameter. Anomalies of the biliary tree related to thedevelopment of a BDI existed in two cases: a low conflu-ence of the hepatic ducts with the cystic duct draining intothe right hepatic duct; and a Mirizzi syndrome that facili-

Table 4. Etiology of bile duct injury

Opencholecystectomy(n:19)

Laparoscopiccholecystectomy(n:16)

Cystic duct confusion 4 5Hartmann’s pouch dissection 9 4Difficult hemostasia 1 —Cystic duct cannulation 1 3Choledochotomy 1 —Instrumental perforation 2 —Others — 4

Table 5. Types of bile duct injury

Opencholecystectomy(n:19)

Laparoscopiccholecystectomy(n:16)

Complete transection 6 5Partial section 1 2Longitudinal tear 4 —Puntiform injury 4 4Posterior wall injury 3 —Cystic–hepatic junction — 5Unknown 1 —

Table 6. Technique for repairing the bile duct injury

Opencholecystectomy(n:19)

Laparoscopiccholecystectomy(n:16)

End-to-end anastomosis 3 3Hepaticojejunostomy 3 4Suture of a T tube 7 3T tube — 4Conservative 1 —Suture simple 4 —Choledocoduodenostomy 1 —Cystic ligature — 2

Table 3. Bile duct injury incidence according to the existence of intraop-erative difficulties

Opencholecystectomy

Laparoscopiccholecystectomy

N % N %

Cholecystectomy withoutincidence 4/1839 0.2 8/1069 0.74

Cholecystectomy plus bileduct examination 6/683 0.9 0/30 0

Difficult cholecystectomy 8/524 1.5 8/601 1.3

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tated the confusion of the cystic duct with the bile duct dueto the presence of a stone located in the bilobiliary fistula.All BDIs occurred in cases operated by surgeons welltrained in laparoscopic surgery with experience in over 50LCs.

Forty-six percent of the patients developed early post-operative morbidity: bile leakage (two), impossibility of re-trieving the T tube due to intraabdominal adhesions thatrequired a minilap for retrieval, and dehiscence of hepati-cojejunostomy. One patient died after multiorgan failure.Mean stay was 23 ± 23 days (range 6–103). After a meanfollow-up of 36 months, two patients developed late mor-bidity (incisional hernia and bile duct stenosis that requiredhepaticojejunostomy).

Converted patients.

In three out of 109 (2.7%) patients that were converted asevere BDI occurred (Table 2). The preoperative diagnoseswere acute cholecystistis, biliary pancreatitis, and bile ductstones. In all three patients, the reason for conversion was asevere distortion of anatomy. In two patients, a completetransection of the bile duct occurred, and in one, a partialsection. Two of them were treated with reconstruction overa T tube, and one with Roux Y hepaticojejunostomy. Onepatient died after reoperation due to hemorrhage, and onedeveloped a biliary fistula that closed spontaneously. Post-operative stay was 28 ± 24 days. One patient developed anincisional hernia that need surgical repair several monthslater.

Discussion

BDIs are severe complications of biliary surgery mainlybecause they cause serious morbidity and are potentiallylethal. This effect is increased when BDI occurs after LC, asurgical procedure designed to increase postoperative com-fort and to shorten the postoperative period.

Soon after widespread use of LC, several authors de-tected a higher rate of BDI referral to specialized centers [6,8, 11]. However, objective data to support this finding, justas some years ago with open BDI, is not easy to find.Analysis from cumulative series seems to indicate that LCcarries a higher risk of BD injury (Table 1).

A more accurate and simple way of identifying rise inBDI incidence is to compare operations performed in simi-lar settings with similar indications, as this paper does. Todate, five papers have reported data [4, 7, 13, 14, 16, 18].Brune et al. [4] reported a similar incidence of BDI (0.2%)after LC or OC in an analysis of an institution, but there wasa bias because LC included simpler cases than OC. Mor-genstern et al. [13, 14] showed, for a series of 3,000 LCs,twice the incidence of BDI (0.5 vs 0.2) after LC comparedto after OC. Three surveys (Connecticut, Holland, and Nor-way) [7, 16, 18] showed higher incidence of BDI after LC,but analysis of one of them over a 3-year period (1991-93)[16] revealed higher initial incidence of BDI, which de-clined in the 2nd year and was comparable to OC in the 3rdyear. These findings suggest a learning curve adaptation.

An evident fact is that the spectrum of BDI has changed.The use of diathermic hooks with more dissection in the

Calot triangle, the use of clips for cystic duct ligature and,mainly, the special features of laparoscopic surgery havemodified the characteristics of the BD injuries. The mostserious lesion is transection of the bile duct. The cause isusually misidentification of the cystic duct. The lesion canbe linked to resection of a segment of bile duct and tovascular injury. This lesion occurred in our series two timesmore often after LC than in the open group, just as otherstudies found [7, 10, 13]. The lesion is usually a conse-quence of the inadequate exposure of the confluence of thecystic duct and Hartmann’s pouch. Although all six caseswere diagnosed during operation, IOC enables the lesion tobe detected before the duct is severed.

The role of IOC in preventing BDI is controversial.Some authors suggest that in spite of the existence of a BDI,IOC often shows as normal or is not properly interpreted bythe surgeon [3, 9]. In Morgenstern’s series [13, 14], IOCdiagnosed 11 of 12 BDIs. Woods et al. [25], in a cumulativereport on 177 BDIs after LC, showed that more BDIs werediagnosed perioperatively in patients on whom an IOC wasperformed and that these patients needed fewer surgicalrepairs than patients diagnosed later. In our series, IOCdiagnosed 67% of cases in the open group and two out offive in the laparoscopic group. However, BDI during LCcan occur after a normal IOC. Dissection of the adherentHartmann’s pouch, excessive electrocautery dissection nearthe bile duct, or difficulties in the management of the cysticduct stump can induce BDI. During open surgery, IOC wasa rare source of BDI [24], but during LC, lesions of thecystic duct or at the confluence can occur because the cath-eters for IOC are straighter and more rigid and the insertionmaneuvers are more difficult. In some series of BDI afterLC, up to 20% are caused by an attempted IOC [23]. In thisseries, a tear in the bile duct occurred while dissecting inorder to have enough length of cystic duct. It was repairedwith the laparoscopic insertion of a T tube. Immediate IOCshowed the anomaly of a short cystic duct that connected toa right hepatic duct.

BDI can be diagnosed in the immediate postoperativeperiod. The avoidance of routine drainage and the moreliberal use of cautery or clips may cause delayed leaks notseen during LC. In our series, one patient was diagnosed inthe early postoperative period in the open group (0.03%),but there were four cases in the LC group (0.23%). All thesecases needed reoperation due to bile peritonitis. A selectivepolicy of drainage is advisable, especially in cases withdifficult dissection or wide, raw, or denuded subhepatic ar-eas.

Two factors that can cause BDI during open surgery arecommonly accepted: local anatomy and the experience ofthe surgeon. In the open series, BDI increased sharply bothin difficult cases and in the hands of more experiencedsurgeons, probably because difficult operations were per-formed by these surgeons. The analysis of our series, alsoshows that technical difficulty arising from anatomy distor-tion and scarring affected the incidence of BDI. Russell etal. [16], in a state-wide analysis, also showed that previousacute cholecystitis (odds ratio:3.3) and biliary pancreatitis(odds ratio:3.6) increased significantly the risk of BDI (p <0.01).

Surgeon’s experience in LC is more difficult to assessaccurately because it involves the learning curve of the en-

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tire surgical team. Some initial data revealed that the mostimportant risk of BDI was during the first dozen LCs; theanalysis of the Connecticut LC records revealed a trendtoward lower incidence of severe BDI after the wide imple-mentation of LC [16]. An interesting analysis of 8,800 LCsperformed by The Southern Surgeons Club [23] showed thatthe risk of BDI caused by an experienced surgeon fell from1.7% during the first case to 0.17% after the first 50. Butanalysis of the present and other data indicate that risk of aBDI exists despite adequate training due to the special fea-tures of laparoscopic surgery. Morgenstern et al. [14] ob-served in a series of 3,000 LCs performed in the Cedars ofSinai Hospital a similar BDI rate (0.5%) in the first 1,500LCs compared to the second series of 1,500. In the presentstudy’s series of LC, most BDI took place under surgeonswho had done more than 50 LCs and sometimes many more.This strongly suggests that the risk of BDI is always presentdue to the features of laparoscopic surgery and in spite ofthe skill of the surgeon.

Modifications of biliary anatomy can cause BDI, but arenot frequent. In the open series, no case was consideredsecondary to biliary anomaly, but in two cases in the LCgroup a biliary anomaly favored BDI (cystic duct drainagein right hepatic duct and Mirizzi syndrome). In the study byAndren-Sandberg et al. [1] an anatomic anomaly was con-sidered responsible for BDI only in 20% of BDI patients.

As in the open group, severe BDI during LC occurredmore frequently in nondilated ducts (<7 mm). No structureshould be severed without confirmation that it is the cysticduct: In this context, selective IOC is likely to be extremelyhelpful.

Most lesions in both groups were diagnosed periopera-tively and repaired. No cases in this series were diagnosedmore than 1 week after LC, either as stricture or stenosis. Itis noteworthy that three cases were resolved by laparoscopywith the simple insertion of a T tube and IOC to monitor,and that a BDI does not neccessarily imply conversion.However, in both series (OC and LC) it is clear that BDI, inspite of primary repair, was associated with high immediate(50 vs 43%) and late morbidity (35 vs 25%) and prolongedhospital stay (25 vs 24 days).

An important finding is that the incidence of BDI inconverted patients was significantly higher than after OC orLC (2.5 vs 0.5 vs 0.8,p < 0.05). It has been suggested thatconversion is a risk factor for complications after LC [23].The incidence can probably be explained by the fact that thegroup of converted patients included acute situations (bleed-ing) in which the surgeon had to act quickly, or more prob-ably because these were those more difficult cases with adistorted or inflamed anatomy.

References

1. Andren-Sandberg A, Alinder G, Bengmark S (1985) Accidental le-sions of the common bile duct at cholecystectomy: pre and perioper-ative factors of importance. Ann Surg 201: 328–332

2. Asbun HJ, Rossi RL, Lowell JA, Munson JL (1993) Bile duct injuryduring laparoscopic cholecystectomy: mechanism of injury, preven-tion and management. World J Surg 17: 547–552

3. Barkun JS, Fried GM, Barkun AN, Sigman HH, Hinchey EJ, GarzonJ (1993) Cholecystectomy without operative cholangiography. Impli-cations for common bile duct injury and retained common bile ductstones. Ann Surg 218: 371–379

4. Brune IB, Scho¨nleben K, Omran S (1994) Complications after lapa-roscopic and conventional cholecystectomy: A comparative study.HPB Surg 8: 19–25

5. Davidoff AM, Pappas TN, Murray EA, Hilleren DJ, Johnson RD,Baker ME (1992) Mechanism of major biliary injury during laparo-scopic cholecystectomy. Ann Surg 215: 196–202

6. Garden OJ (1991) Iatrogenic injury to the bile duct. Br J Surg 78:1412–1413

7. Gouma DJ, Go PMNYH (1994) Bile duct injury during laparoscopicand conventional cholecystectomy. J Am Coll Surg 178: 229–233

8. Keith RG (1993) Is the increasing frequency of laparoscopic bile ductinjury justifiable? Can J Surg 36: 501–502

9. Lorimer JW, Fairfull RJ (1995) Intraoperative cholangiography is notessential to avoid duct injuries during laparoscopic cholecystectomy.Am J Surg 169: 344–347

10. McMahon AJ, Fullarton G, Baxter JN, O’Dwyer PJ (1995) Bile ductinjury and bile leakage in laparoscopic cholecystectomy. Br J Surg 82:307–313

11. Moossa AR, Easter DW, Van Sonnenberg E, Casola G, D’Agostino H(1992) Laparoscopic injuries to the bile duct. Ann Surg 215: 203–208

12. Morgenstern L, Berci G, Pasternak H (1993) Bile leakage after biliarytract surgery. Surg Endosc 7: 432–438

13. Morgenstern L, Wong L, Berci G (1992) Twelve hundred consecutivecholecystectomies before the laparoscopic era: Morbidity and mortal-ity and general observations. Arch Surg 127: 400–403

14. Morgenstern L, McGrath MF, Carroll BJ, Paz-Partlow M, Berci G(1995) Continuing hazards of the learning curve in laparoscopic cho-lecystectomy. Am Surg 61: 914–918

15. Richardson MC, Bell G, Fullarton GM, West Scotland LaparoscopicCholecystectomy Audit Group (WSLCAG) (1996) Incidence and na-ture of bile duct injuries following laparoscopic cholecystectomy: anaudit of 5913 cases. Br J Surg 83: 1356–1360

16. Russell JC, Walsh SJ, Mattie AS, Lynch JT (1996) Bile duct injuries,1989–1993. A statewide experience. Arch Surg 131: 382–388

17. Schol FPG, Go PMNYH, Gouma DJ (1994) Risk factors for bile ductinjury in laparoscopic cholecystectomy. Br J Surg 81: 1786–1788

18. Solheim K, Buanes T (1995) Bile duct injury in laparoscopic chole-cystectomy. Int Surg 80: 361–364

19. Stewart L, Way LW (1995) Bile duct injuries during laparoscopiccholecystectomy. Arch Surg 130: 1123–1129

20. Strasberg SM, Hertl M, Soper NJ (1995) An analysis of the problemof biliary injury during laparoscopic cholecystectomy. J Am Coll Surg180: 101–125

21. Targarona EM, Garcia-Olivares E, Mun˜oz E, Centeno J, Otal C, MarcoML (1991) Lesion quirurgica de la vı´a biliar. Cir Esp 49: 20–27

22. Targarona EM, Garcia Olivares E, Marco C (1992) When and why bileduct injury occurs. HPB Surg 5(Suppl): 8

23. The Southern Surgeons Club, Moore MJ, Bennett CL (1995) Thelearning curve for laparoscopic cholecystectomy. Am J Surg 170: 55–59

24. White TT, Hart MJ (1985) Cholangiography and small duct injury. AmJ Surg 149: 640–643

25. Woods MS, Traverso LW, Kozarek RA, Donohue JH, Fletcher DR,Hunter JG (1995) Biliary complications of laparoscopic cholecystec-tomy are detected more frequently with routine intraoperative cholan-giography. Surg Endosc 9: 1076–1080

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SymposiumCo-chairs: Bruce Schirmer, L. William Traverso

SSAT/SAGES minimally invasive surgery

Advanced laparoscopic hepatobiliary surgery

Intraoperative screening for common duct stones:ultrasound or cholangiography?

Nathanial J. Soper, St. Louis, MO, USAERCP: when preop, when postop, ever intraop?

Richard A. Kozarek, Seattle, WA, USATranscystic CBD exploration

Edward H. Phillips, Los Angeles, CA, USACholedochotomy and CBD exploration

Joseph B. Petelin, Shawnee Mission, KS, USALaparoscopic treatment of hepatic cystic disease

Lawrence Way, San Francisco, CA, USALaparoscopic screening for RUQ tumors andhepatic metastases

Fredrick L. Greene, Columbia, SC, USALaparoscopic biliary bypass for unresectable malignancy

Lee L. Swanstrom, Portland, OR, USALaparoscopic hepatic resection

Ricardo Rossi, Burlington, MA, USA

Introduction

The Society for Surgery of the Alimentary Tract (SSAT)and the Society of American Gastrointestinal EndoscopicSurgeons (SAGES) jointly sponsored the following series oftalks given during the 1997 Digestive Disease Week held inWashington, D.C. Experts with experience in minimallyinvasive surgery of the hepatobiliary tract, all members ofeither one or both of the sponsoring societies, presentedinformation on topics considered to be at the ‘‘cuttingedge’’ of this approach to diseases of the liver and biliarytract. These experts were chosen on the basis of their expe-rience; often they are the recognized foremost authority ontheir particular topic in the country. As a result, the discus-sions were enhanced by the presenter’s individual clinical

experiences and understanding of the nuances of these treat-ments.

These summaries attempt to convey the core knowledgepresented during the symposium. Along with the selectedreadings at the end of each summary, they are an excellentoverview of the topic and allow the reader to review thelatest information with respect to the dynamic applicationsof minimally invasive surgery to this area of general sur-gery.

Bruce Schirmer

Department of SurgeryUniversity of Virginia Health Science CenterBox 181Charlottesville, VA 22908, USA

© Springer-Verlag New York Inc. 1998Surg Endosc (1998) 12: 361–373

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Intraoperative screening forcommon bile duct stones

Ultrasound or cholangiography?

Intraoperative screening of the common bile duct for stonesduring laparoscopic cholecystectomy can be done usingcholangiography or ultrasonography. Application of one ofthese modalities for screening of the duct may be performedeither routinely or selectively, a debate that has been re-awakened by the emergence of laparoscopic cholecystecto-my. Recently, a number of studies have compared intraop-erative cholangiography (IOC) to laparoscopic intracorpo-real ultrasonography (LICU) for screening of the commonbile duct during laparoscopic cholecystectomy.

When performing cholangiography, radio-iodinatedcontrast material may be injected either into the gallbladderdirectly or into the cystic duct, and radiographic images maybe obtained by static or dynamic (fluoroscopic) techniques.A consensus is emerging that fluoroscopic cholangiographyperformed with intubation of the cystic duct should be theprimary method for IOC. The overall success rate for ob-taining adequate images by laparoscopic intraoperativecholangiography varies from 60 to 98% with false-positiveand false-negative rates of less than 5%. Potential negativesof cholangiography are the need to intubate the cystic duct,with the possibility of ductal injury occurring as a directresult of the intubation, and the time and cost expended onthe examination itself.

During open cholecystectomy, several studies showedintracorporeal ultrasonography to be more accurate than op-erative cholangiography in assessing the common bile duct(CBD) for stones (97–99% vs 89–94%). However, few sur-geons adopted ultrasound for this purpose. Laparoscopicintracorporeal ultrasound has been used in several centers toscan the biliary tree during laparoscopic cholecystectomy.With intracorporeal ultrasonography, the transducer may beof higher frequency and improved resolution compared tothat used with transabdominal ultrasonography. Ultrasonog-raphy may be used to map the extrahepatic ductal system,identify anomalies of ductal and vascular structures, quan-

tify ductal diameter, and visualize CBD stones and sludge.In experienced hands, laparoscopic intracorporeal ultraso-nography appears to be more sensitive than cholangiogra-phy for demonstrating choledocholithiasis, whereas cholan-giography may be more accurate for demonstrating biliaryanatomy. Thus, the two studies appear to be complementaryfor the delineation of biliary disease. Several studies haveshown laparoscopic ultrasonography to screen the bile ductmuch more rapidly than cholangiography and LICU costsapproximately $145 less than IOC per examination (unpub-lished results). Despite these promising data, more clinicalexperience will be necessary to establish the appropriaterole for laparoscopic intracorporeal ultrasonography forscreening the common bile duct during laparoscopic chole-cystectomy.

Selected readings

Cuschieri A, Shimi S, Banting S, Nathanson LK, Pietrabissa A (1994)Intraoperative cholangiography during laparoscopic cholecystectomy.Routine vs. selective policy. Surg Endosc 8: 302–305

Jones DB, Soper NJ (1995) Results of a change to routine fluorocholan-giography during laparoscopic cholecystectomy. Surgery 118: 693–702

Orda R, Sayfan J, Strauss S, et al. (1994) Intraoperative ultrasonography asa routine screening procedure in biliary surgery. Hepatogastroenterol-ogy 41: 61–64

Machi J, Siegel B, Zaren HA, et al. (1993) Operative ultrasonographyduring hepatobiliary and pancreatic surgery. World J Surg 17: 640–646

Machi J, Sigel B, Zaren A, et al. (1993) Technique of ultrasound exami-nation during laparoscopic cholecystectomy. Surg Endosc 7: 545–549

Stiegmann GV, McIntyre RC, Pearlman NW (1994) Laparoscopic intra-corporeal ultrasound: an alternative to cholangiography? Surg Endosc8: 167–172

Teefey SA, Soper NJ, Middleton WD, Balfe DM, Brink JA, Strasberg SM,Callery MP (1995) Imaging of the common bile duct during laparo-scopic cholecystectomy: sonography versus videofluoroscopic cholan-giography. Am J Roentgenology 165: 847–851

Nathaniel J. Soper

Department of SurgeryWashington UniversitySchool of MedicineSt. Louis, MO, USA

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ERCP interaction withlaparoscopic cholecystectomy

Alternatives

Endoscopic retrograde cholangiopancreatography (ERCP)interaction with laparoscopic cholecystectomy (LC) is aseesaw which is contingent both upon local endoscopic andsurgical expertise. In institutions in which endoscopists areuncertain of their diagnostic or therapeutic ERCP capabili-ties, any patient with the potential for a common bile ductcalculus is likely to undergo a preoperative endoscopiccholangiogram with attendant attempt at some extraction ifone is found. This is especially true if the surgeon perform-ing the laparoscopic cholecystectomy has limited experi-ence in performing intraoperative cholangiography (IOC),let alone transcystic or laparoscopic common bile duct ex-ploration (LCBDE).

Alternatives to preoperative ERCP for choledocholithi-asis include intra- or postoperative ERCP or laparoscopic oropen common bile duct exploration. Intraoperative biliarysphincterotomy, in turn, can be performed either conven-tionally or by means of an endoscopically visualized pap-illotome placed laparoscopically across the sphincterthrough the cystic duct. More commonly, however, ERCPand laparoscopic cholecystectomy interact in the postopera-tive setting in patients who develop symptoms (biliary colic,cholestasis, pancreatitis) following an uncomplicated lapa-roscopic cholecystectomy. Alternatively, IOC may demon-strate a bile duct stone for which retrieval is unsuccessful ornot attempted.

Results

Most reported series in which ERCP-LC interaction hasbeen recorded have involved preoperative ERCP in patientswith suspected common bile duct stones. Moreover, in arecently published prospective series evaluating endoscopicinteraction with laparoscopic cholecystectomy, communityendoscopists were 1.67 times more likely to perform pre- asopposed to postoperative ERCP. Prospectively comparing780 ERCPs performed in the setting of LC, data from 14biliary endoscopists at four academic medical centers wascompared to that from 33 community-based gastroenterolo-gists, 23 of whom had performed less than 500 total ERCPs.Four hundred ninety-three of these patients (63%) under-went preoperative ERCP for a variety of indications includ-ing abnormal liver function tests (≈90%), jaundice (≈50%),fever (≈33%), or pancreatitis (≈35%). Forty-three percent ofthese patients were found to have stones, suggesting thatover half of these individuals incurred the risk and expenseof the procedure with the only potential benefit being defi-nition of biliary tract anomalies or preclusion of need forintraoperative cholangiography.

Although there have been techniques described to effectprograde sphincterotomy through the cystic and commonduct, most laparoscopists who utilize intraoperative ERCPapproach the sphincter in a retrograde fashion. I find eithertechnique cumbersome and logistically problematic. Intra-

operative ERCP can best be described ashow to make astraightforward procedure difficult:Do it ‘‘on-call’’ in theOR; use suboptimal radiographic equipment; perform it in asupine position (rather than the usual prone position); andinflate the bowel, making the laparoscopy itself more dif-ficult.

In contrast to pre- or intraoperative ERCP, individualsand institutions with extensive endoscopic experience tendto shift ERCP interaction with LC to the postoperative set-ting. This is particularly true in institutions in which sur-geons have experience with IOC and LCBDE. In the lattersetting, successful stone retrieval precludes the risks asso-ciated with sphincterotomy or balloon dilation of the pa-pilla. It also precludes the additive expenses of ERCP (roomcharge and professional fee) as well as the need for 1–2 daysof additional hospital time. ERCPs in this setting should belimited to patients in whom attempted LCBDE proves un-successful or those patients who develop signs or symptomsof biliary calculi, leak, or stenoses postoperatively. Thisapproach implies confidence in one’s endoscopic capabili-ties because an unsuccessful LCBDE would then requireopen surgical intervention. In the previously cited review byDavis et al., 59% of ERCP interactions with LC occurredpostoperatively in the four academic medical centers,whereas 69% of the ERCPs performed by community-basedgastroenterologists were undertaken preoperatively. Ourgroup, in turn, reported that 92% of ERCP-LC interactionsin our institution were in the postoperative setting. In con-trast to a 50% normal ERCP rate in series reporting a pre-ponderance of preoperative exam, only 7% of our patientgroup had normal studies. Pathology included choledocho-lithiasis (31%), biliary leak and/or stricture (26%), cysticduct leak (6%), and papillary stenosis/microlithiasis (19%).In addition, six patients (11%) were studied for postopera-tive pancreatitis; four of these patients were found to havebiliary gravel/microlithiasis in conjunction with sphincterdysfunction and two were felt to have passed common ductcalculi.

Recommendations

Given the above, and given the additive expense and risks ofcombining laparoscopic cholecystectomy with ERCP, I rec-ommend that the latter be undertaken primarily in the post-operative setting. The latter presupposes that my laparo-scopic colleagues have or will develop the capabilities to doboth IOC and LCBDE. This will decrease the number ofERCPs needed because only patients with retained stones orpostoperative symptoms will undergo a procedure. It willalso decrease the potential problems that occasionally occurfollowing long-term sphincter ablation. It does, however,imply an onus on the endoscopist: Be successful or thepatient may require a third procedure. Each endoscopist hasa variable degree of comfort level with this onus. Mine stopswith Roux-en-y and perhaps Billroth II anatomy. I shiftpatients such as these into a preoperative study knowing thatmy failure and the failure of LCBDE to remove commonduct stones can be overcome by conversion to an openprocedure at time of LC. Moreover, ill patients with acutecholangitis and a subset with severe pancreatitis may havedramatic amelioration of their symptoms following success-

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ful ERCP and stone removal. I tend to shift these patientsinto a preoperative setting also, reasoning that life-threatening situation and need for urgent surgery can becontrolled acutely, allowing a subsequent laparoscopic pro-cedure electively.

Ours is a codependent situation given that both the per-formance and the timing of ERCP in conjunction with LCwill be contingent upon the players and their aptitudes. Bynecessity, practice patterns will be institutionally defined.

Selected readings

Berci G, Morgenstern L (1994) Laparoscopic management of common bileduct stones: a multi-institutional SAGES study. Surg Endosc 8: 1168–1175

Davis WZ, Cotton PB, Arias R, et al. (1997) ERCP and sphincterotomy inthe context of laparoscopic cholecystectomy. Academic and communitypractice patterns and results. Am J Gastroenterol 92: 597–601

Esber EJ, Sherman S (1996) The interface of endoscopic retrograde chol-angiopancreatography and laparoscopic cholecystectomy. GastrointestEndosc Clin North Am 6: 57–80

Kozarek RA (1993) Laparoscopic cholecystectomy: what to do with thecommon duct. Gastrointest Endosc 39: 99–100

Kozarek RA, Gannan R, Baerg R, et al. (1992) Endoscopic approach to bileleak following laparoscopic cholecystectomy. Arch Intern Med 152:1040–1043

Kozarek RA, Ball TJ, Patterson DJ, et al. (1994) Endoscopic biliary injury

in the era of laparoscopic cholecystectomy. Gastrointest Endosc 40:10–16

Perissat J, Huibregtse K, Keane FBV, et al. (1994) Management of bileduct stones in the era of laparoscopic cholecystectomy. Br J Surg 81:799–810

Rhodes M, Nathanson L, O’Rourke N, et al. (1995) Laparoscopic explo-ration of the common bile duct: lessons learned from 129 consecutivecases. Br J Surg 82: 666–668

Rieger R, Wayand W (1995) Yield of prospective, noninvasive evaluationof the common bile duct combined with selective ERCP/sphincter-otomy in 1390 consecutive laparoscopic cholecystectomy patients. Gas-trointest Endosc 42: 6–12

Strasberg SM, Soper NJ (1995) Management of choledocholithiasis in thelaparoscopic era. Gastroenterology 109: 320–322

Strasberg SM, Callery MP, Soper NJ (1996) Laparoscopic surgery of thebile ducts. Gastrointest Endosc Clin North Am 6: 81–106

Toouli J (1997) Preoperative endoscopic sphincterotomy. In: Berci G, Cus-chieri A (eds). Bile ducts and bile duct stones. WB Saunders, Phila-delphia, pp 116–119

Traverso LW, Kozarek RA, Ball TJ, et al. (1993) ERCP after laparoscopiccholecystectomy. Am J Surg 165: 581–586

Welbourn CRB, Mehta D, Armstrong CP, et al. (1995) Selective preop-erative ERCP with sphincterotomy avoids bile duct exploration duringlaparoscopic cholecystectomy. Gut 37: 576–579

Richard A. Kozarek

Section of GastroenterologyVirginia Mason Medical CenterSeattle, WA, USA

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Laparoscopic transcystic ductcommon bile duct exploration

Background

Laparoscopic techniques of transcystic common bile ductexploration (LTCBDE) treat common duct stones in onesession and avoid the potential complications of endoscopicsphincterotomy. These techniques include simple lavage,fluoroscopic-guided stone extraction using balloon cathetersor wire baskets, biliary endoscopy with wire basket stoneretrieval, intraoperative endoscopic or antegrade sphincter-otomy, and lithotripsy techniques. The indications forLTCBDE include filling or equivocal defects on cholangi-ography, stone size less than 10 mm, fewer than nine stones,and possible tumor. The contraindications include stonesproximal to the cystic duct entrance into the common bileduct and small/friable cystic duct.

Choledochoscopic transcystic duct common bileduct exploration

Choledochoscopic transcystic duct common bile duct(CBD) exploration is applicable in 80–90% of patients withCBD stones. The choledochoscope (2.7–3.2 mm diameter)should have bidirectional deflection and a 1.2-mm workingchannel. It requires cystic duct dilation with a balloon-dilating catheter or ureteral dilation bougies. Stones are vi-sualized and a wire basket is passed through the workingchannel to entrap the stone. An effort is made to pass thescope up into the liver, although this can only be performedin approximately 10% of cases. The technique is successfulin cleaning the common duct of stones in over 90% of cases.

Fluoroscopic basket stone retrieval

Fluoroscopic basket stone retrieval is less expensive thancholedochoscopy and is successful approximately 60% ofthe time. Special spiral wire baskets with flexible leadersmust be used to avoid injury to the common bile duct. Theadvantage of not having to dilate the cystic duct is offset bythe problem of extracting the basket with an entrapped stonethrough a nondilated cystic duct.

Biliary balloon catheter trolling

Biliary balloon catheter trolling is occasionally helpful incases with a dilated cystic duct and stones that ‘‘float.’’ Thedrawback to this technique is the potential to pull the stoneinto the common hepatic duct, out of reach of an endoscope.

Ampullary balloon dilation

Ampullary balloon dilation is a controversial technique. Itsadvantage is that it can be employed when the cystic duct isextremely small and an endoscope cannot be inserted. Aradial expanding balloon is placed under fluoroscopic guid-

ance to span the sphincter. Hyperamylasemia often follows,and severe pancreatitis may occur.

Other techniques

Fitzgibbons recommends placing a ureteral catheter throughthe cystic duct into the duodenum. This catheter is used toperform guide-wire-assisted ERCP postoperatively. De-Paulo and Zucker have treated small numbers of patients,with good results, using antegrade sphincterotomy via thecystic duct during laparoscopic cholecystectomy (LC). Agastroscope must be inserted orally to observe the orienta-tion of the papillotome.

Summary and recommendations

A recent prospective multicenter study of endoscopicsphincterotomy (ES) in 1,494 patients showed procedure-related morbidity at 7.4% when ES was performed in con-junction with LC, procedure-related mortality of 0.5%, andtotal mortality of 2.2%. Therapeutic recommendations forpatients with suspected common bile duct stones shouldconsider these more inclusive morbidity figures. Theyshould also reflect the immediate risks of pancreatitis,bleeding, and perforation and the delayed risk of stricture.These risks may exceed those of open common bile ductexploration in younger patients, especially with small-diameter common ducts, but are similar to laparoscopiccommon bile duct exploration (CBDE) in patients over 65years of age. Some reports indicate that open CBDE hasalmost no mortality in patients under age 60, but 2–4.3%mortality in those over age 60.

The experience with LTCBDE of our group, De Paulaand Petelin, shows that the approach is applicable in morethan 85% of cases and is successful in 85–95% of cases.Complications do occur (6% major and 12% minor), butthese also include complications associated with LC. Therewere only two LTCBDE procedure-related complications inour series of 193 LTCBDEs, no mortality in patients under65, and one death (<1%) in a patient over 65. Comparingthese outcomes with either ES or open common bile ductexploration, the data show that patients under age 65 haveimproved outcomes with LTCBDE, and those over 65 havecomparable outcomes with ES or LTCBDE, but only re-quire a single procedure with LTCBDE.

Choledochoscopy via the cystic duct appears to be themost effective (90%) and safest approach to the commonduct. Nevertheless, it is possible to employ fluoroscopicbasket retrieval in many cases (60%). Even irrigation andtrolling with a biliary balloon catheter will be effective insome cases. Ampullary balloon dilation should be per-formed when the only alternative is ES. Leaving a catheterin the cystic duct or a transampullary biliary stent will en-sure successful postoperative sphincterotomy. Antegradesphincterotomy should be reserved for the 5–10% of com-plex cases that require a drainage procedure. Lithotripsy,either with electrohydraulic or laser energy, is best em-ployed via a choledochotomy because of the resultant de-bris. Further technological advances will facilitate the ap-plication and adoption of laparoscopic approaches to the

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common duct, which should become the primary strategy inthe great majority of patients.

Selected readings

Carroll BJ, Phillips EH, Chandra M, Fallas MJ (1993) Laparoscopic trans-cystic duct balloon dilation of the sphincter of Oddi. Surg Edosc 7:514–517

Curet M, Pitcher D, Martin D, Zucker K (1995) Laparoscopic antegradesphincterotomy: a new technique for the management of complex cho-ledocholithiasis. Ann Surg 221(2): 149–155

DePaulo A, Hashiba K, Bafutto M, Zago R, Machado M (1993) Laparo-scopic antegrade sphincterotomy. Surg Laparosc Endosc 3(3): 157–160

De Paula AL, Shashiba K, Bafutto M (1994) Laparoscopic management ofcholedocholithiasis. Surg Endosc 8: 1399–1403

Fitzgibbons RJ, et al. (1995) An alternative technique for treatment ofcholedocholithiasis. Arch Surg 130: 638–642

Freeman M, Nelson D, Sherman S, et al. (1994) Complications of endo-scopic sphincterotomy (ES); a prospective multicenter 30-day outcomestudy. The Hennepin Count Medical Center, Minneapolis, MN and theMESH Study Group Abstract World Congress of Gastroenterology,October 2–7, 1994, Los Angeles, CA, USA

Hunter JG, Soper NJ (1992) Laparoscopic management of bile duct stones.Surg Clin North Am 72(5): 1077–1080

Jones DB, Soper NJ (1996) The current management of common bile ductstones. Adv Surg 29: 271–289

Lezoche E, Paganini M (1995) Single stage laparoscopic treatment ofgallstones and common bile duct stones in 120 unselected, consecutivepatients. Surg Endosc 9: 1070–1075

Morgenstern L, Wong L, Berci G (1992) Twelve hundred open cholecys-tectomies before the laparoscopic era. A standard for comparison. ArchSurg 127: 400–403

Petelin J (1991) Laparoscopic approach to common bile duct pathology.Surg Laparosc Endosc 1: 33–41

Phillips EH, Carroll BJ, Pearlstein AR, Daykhovsky L, Fallas MJ (1993)Laparoscopic choledochoscopy and extraction of common bile ductstones. World J Surg 17(1): 22–28

Rhodes M, Nathanson L, O’Rourke N, Fielding G (1995) Laparoscopicexploration of the common bile duct: lessons learned from 129 con-secutive cases. Br J Surg 82: 666–668

Edward H. Phillips

Department of SurgeryCedars-Sinai Medical CenterLos Angeles, CA, USA

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Laparoscopic choledochotomy fortreatment of common bileduct stones

Introduction

According to some reports, up to 10% of patients who un-dergo laparoscopic cholecystectomy harbor common bileduct stones. Laparoscopic common bile duct exploration(LCDE), which in experienced centers yields ductal clear-ance rates >90%, has become the gold standard for single-stage management of choledocholithiasis and is the mostefficient method of handling this problem.

A number of techniques are available to accomplishcholedocholithotomy. These include pharmacological andflushing techniques, balloon catheter manipulations, baskettechniques with and without fluoroscopy, and choledo-choscopic techniques. In the author’s experience, and inmany series, choledochoscopic exploration is used most fre-quently, as much as 63% of the time. Balloon extractionmethods are usually combined with flushing and pharma-cological techniques. These account for approximately 26%of ductal explorations. Basket techniques, utilized in 11% ofthe author’s cases, may be employed either with the fluo-roscope or without it, although the latter method requires agreater degree of skill and risk management by the surgeonin order to avoid perforation of the duct or capture of thepapilla.

Ductal exploration may be accomplished through thecystic duct or directly through the common bile duct. Inmost cases, the common duct may be explored through thecystic duct. However, in some situations choledochotomy isnecessary or even preferred. The problem is deciding whichapproach is best for a given case. There are specific indi-cations for the employment of each access route, and eachis equally effective in clearing the ductal system in theappropriate setting. While the transcystic route is the leastinvasive and generally does not require any subsequent duc-tal manipulation or drainage procedure, the choledo-chotomy route requires either closure of the duct over aT-tube or primary closure of the choledochotomy without aT-tube.

Transcystic vs transductal approach

Factors influencing the choice of access route for LCDE areincluded in Table 1. Note that it is usually a negative influ-ence, precluding the use of a given access route, rather thana positive influence, permitting the use of one, that deter-mines which route is preferred.

In the author’s series, 85% of ductal explorations wereperformed with the transcystic route. Fifteen percent ofcases required choledochotomy. Most American series par-allel this same approach. The transcystic method is the leastinvasive and is associated with shorter operating times,shorter length of stay, and the greatest patient satisfactionbecause there are usually no tubes left in situ after the pro-cedure.

The choledochotomy and ductal exploration

Most surgeons prefer a longitudinal choledochotomy. Whenperformed laparoscopically, it is usually shorter than inopen choledochotomy (generally no larger than the largeststone) and no ‘‘stay sutures’’ are required. External manipu-lations of the duct, balloon, and basket extraction tech-niques, and choledochoscopic maneuvers are all used toclear the duct. Occasionally, electrohydraulic lithotripsy isused under direct choledochoscopic vision to fragment im-pacted stones. Some authors have added intraoperative an-tegrade sphincterotomy in selected patients, but this is lo-gistically complex and not widely practiced.

T-tubes and T-tube management

T-tubes are used in patients in whom there is concern forpossible retained stones or debris, distal ductal spasm, in-flammation, obstruction, pancreatitis, or general poor tissuequality. T-tubes provide access for ductal imaging in thepostoperative period and a route for removal of residualcommon duct stones, should they be left after common bileduct exploration. Most authors prefer a 14-French latex T-tube (or larger) and ductal closure with an absorbable finesuture such as 4-0 or 5-0 polyglycolic acid. Although sili-cone T-tubes have been used by some authors in the USAand Europe, they are generally not preferred because theydo not excite the degree of tissue reaction necessary toproduce a tract to the surface in the case of persistent bileleakage after removal. Silicone T-tubes, however, havebeen associated with less bacterial contamination than latexT-tubes.

Complications of T-tube placement and removal

Management of T-tubes in the postoperative period may beassociated with bacteremia, dislodgment of the tube, ob-struction by the tube, or fracture of the tube. Removal ofT-tubes postoperatively has been suggested as early as 4days and as late as 6 weeks. Between these two extremeslies the most appropriate management plan. Some authors

Table 1. Factors influencing duct exploration approacha

Factor Transcystic Choledochotomy

One stone + +Multiple stones + +Stonesø6-mm diameter + +Stones >6-mm diameter − +Intrahepatic stones − +Diameter of cystic duct <4 mm − +Diameter of cystic duct >4 mm + +Diameter of common duct <6 mm + −Diameter of common duct >6 mm + +Cystic duct entrance—lateral + +Cystic duct entrance—posterior − +Cystic duct entrance—distal − +Inflammation—mild + +Inflammation—marked + −Suturing ability—poor + −Suturing ability—good + +

a +, positive or neutral effect; −, negative effect.

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recommend broad-spectrum antibiotic coverage while theT-tube is in situ. T-tube cholangiography should be per-formed before removal of the tube. Removal of T-tubes hasbeen associated with bile leaks, peritonitis, and reoperation.The incidence of these complications has generally beenless than 5% in most laparoscopic series.

Primary closure of the choledochotomy

Primary closure of the common bile duct is performed inpatients in whom the exploration successfully cleared allstones, and in which there is no evidence of distal edema,spasm, obstruction, or pancreatitis, and in whom tissue in-tegrity appears substantial. Absorbable suture of 4-0polyglycolic acid is usually used for the closure. This isaccomplished in either a continuous fashion or with inter-rupted suture. A closed-system suction drain is placed ad-jacent to the closure in all cases.

In the author’s series, laparoscopic primary closure ofthe choledochotomy, used in 34% of cases involving cho-ledochotomy, did not result in any complications. There wasno incidence of bile leak, peritonitis, or clinical evidence ofretained bile duct stones. Length of stay is shorter than thatof patients with T-tubes. Patients report a higher degree ofcomfort and satisfaction than those in whom T-tubes hadbeen placed.

Summary

1. Laparoscopic choledocholithotomy via choledochotomyor the cystic duct is feasible and effective when used inthe appropriate situations.

2. Choledochotomy closure with or without T-tube place-ment is feasible and effective.

3. When used in appropriately selected patients, choledo-chotomy closure without T-tube placement does not re-sult in increased complications.

4. Primary closure of the common bile duct without T-tubeplacement is associated with higher patient satisfactionand shorter length of stay than T-tube placement.

5. Transductal common bile duct exploration is more inva-sive than transcystic ductal exploration but less invasiveand less costly than open common bile duct exploration.

Selected readings

Bernstein DE, Goldberg RI, Unger SW (1994) Common bile duct obstruc-tion following T-tube placement at laparoscopic cholecystectomy. Gas-trointest Endosc 40(3): 362–365

Carroll BJ, Phillips EH, Daykhovsky L, Grundfest WS, Gershman A,Fallas M, Chandra M (1992) Laparoscopic choledochoscopy: an effec-tive approach to the common duct. J Laparoendosc Surg 2: 15–21

DePaula A, Hashiba K, Bafutto M, Zago R, Machado M (1993) Laparo-scopic antegrade sphincterotomy. Surg Laparosc Endosc 3(3): 157–160

DePaula AL, Hashiba K, Bafutto M (1994) Laparoscopic management ofcholedocholithiasis. Surg Endosc 8: 1399–1403

Ferzli GS, Massaad A, Kiel T, et al. (1994) The utility of laparoscopiccommon bile duct exploration in the treatment of choledocholithiasis.Surg Endosc 8: 296–298

Fletcher DR (1993) Common bile duct calculi at laparoscopic cholecys-tectomy: a technique for management. Aust NZ J Surg 63: 710–714

Gillatt DA, May RE, Kenedy R, Longstaff AJ (1985) Complications ofT-tube drainage of the common bile duct. Ann R Coll Surg Engl 67:369–371

Horgan PG, Campbell AC, Gray GR, Gillespie G (1989) Biliary leakageand peritonitis following removal of T tubes after bile duct exploration.Br J Surg 76: 1296–1297

Koivusalo A, Makisalo H, Talja A, et al. (1996) Bacterial adherence andbiofilm formation on latex and silicone T-tubes in relation to bacterialcontamination of bile. Scand J Gastroenterol 398–403

Lygidakis NJ (1984) Incidence of bile infection in biliary lithiasis. Effectson postoperative bacteremia of choledochoduodenostomy, T-tubedrainage, and primary closure of the common bile duct after choledo-chotomy—a prospective trial. Am Surg 50: 236–240

Norrby S, Heuman R, Anderberg B, Sjodahl R (1988) Duration of T-tubedrainage after exploration of the common bile duct. Acta Chir Scand154: 113–115

Petelin J (1991) Laparoscopic approach to common duct pathology. SurgLaparosc Endosc 1(1): 33–41

Petelin J (1993) Laparoscopic approach to common duct pathology. Am JSurg 165: 487–491

Stoker ME, Leveillee RJ, McCann JC, Maini BS (1991) Laparoscopiccommon bile duct exploration. J Laparoendosc Surg 1(5): 287–293

Traverso LW (1996) A cost-effective approach to the treatment of commonbile duct stones with surgical versus endoscopic techniques. In: BerciG, Cuschieri A (eds). Bile ducts and bile duct stones. WB Saunders,Philadelphia, pp 154–160

Joseph B. Petelin

University of KansasSchool of MedicineKansas City, KS, USA

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Laparoscopic treatment for rightupper quadrant tumors andhepatic metastasesThe laparoscope should be regarded as a significant tool forboth the diagnosis and staging of abdominal cancer, espe-cially tumors effecting the hepatobiliary tract. The laparo-scope must be utilized in conjunction with other modalitieswhich include radiologic imaging techniques, nuclear medi-cine scans, intraluminal endoscopic studies, and percutane-ous ultrasound. When tumors of the right upper quadrant areassessed, the indication for laparoscopy must be viewed inrelation to the need for celiotomy for overall management.Specifically, the diagnosis of a primary colorectal cancergenerally will mandate resection either by formal open tech-niques or by newer laparoscopic methods. Preoperative lap-aroscopy for the assessment of colorectal cancer metastasesis generally not undertaken except in unusual situationswhen liver involvement is noted without a primary cancerbeing identified. It may be important to preoperatively as-sess the liver, however, in order to discuss the potential ofmetastasectomy with the patient preoperatively as a methodto enhance survival in advanced colorectal cancer.

The concept of ‘‘screening’’ would indicate that there isa high-risk group of patients that may benefit from a par-ticular radiologic or endoscopic study. When viewing this interms of hepatic metastases, it is recognized that liver in-volvement occurs most frequently in gastrointestinal tu-mors, including colorectal cancer and pancreatic and gastriccarcinoma. Less often, breast and lung cancer as well aslymphoma may involve the hepatic parenchyma and maylead to laparoscopic investigation. The important criteria toobserve during laparoscopic evaluation are: (1) the numberof metastases, (2) size of metastases, (3) location of extra-hepatic disease, and (4) extent of hepatic involvement. Theutilization of intraoperative ultrasound may enhance stagingand, in fact, may change the surgical approach in as many as20% of patients who are being evaluated for hepatic resec-tion.

Laparoscopy may be especially important in patientsundergoing lymphoma staging in that inspection of theliver, appropriate biopsy of hepatic lobes, and nodal dissec-

tion can be undertaken. In addition to making a diagnosis ofcancer, benign hepatic tumors may be found. The mostcommon benign tumor is focal nodular hyperplasia (FNH).In addition, hepatocellular adenoma, relating to oral contra-ceptives and hemangiomas may be visualized.

Primary hepatobiliary tumors occur most commonly inSouth America and Southeast Asia. In the United States,gallbladder carcinoma is the most common type of hepato-biliary tumor. Approximately 1% of gallbladders removedwill harbor occult carcinoma. Certain groups in the UnitedStates, such as Native-American women in New Mexico,have a significantly higher rate of gallbladder cancer. Thelaparoscope may be used to confirm imaging studies, pro-vide needle-directed biopsy of the liver or peritoneum, orhelp in surgical decision-making regarding the resectabilityof gallbladder cancer. Similarly, laparoscopy should be uti-lized preoperatively in the assessment of patients with he-patocellular cancer and cholangiocarcinoma of the extrahe-patic biliary ducts. Patients with hepatolithiasis, cystic dis-ease of the extrahepatic biliary tree, and those withsclerosing cholangitis represent high-risk groups for extra-hepatic bile duct cancer.

Selected readings

Dagnini G, Marin G, Patella M, Zotti S (1984) Laparoscopy in the diag-nosis of primary carcinoma of the gallbladder. Gastrointest Endosc 30:289–291

Eubanks S (1994) The role of laparoscopy in diagnosis and treatment ofprimary or metastatic liver cancer. Semin Surg Oncol 10: 404–410

Greene FL, Rosin RD (1995) Minimal access surgical oncology. RadcliffeMedical Press, Oxford

John TG, Greig JD, Crosbie JL, et al. (1994) Superior staging of livertumors with laparoscopy and laparoscopic ultrasound. Ann Surg 220:711–719

Ravikumar TS (1996) Laparoscopic staging and intraoperative ultrasonog-raphy for liver tumor management. North Am Surg Oncol Clin 5:271–282

Frederick L. Green

Department of General SurgeryCarolinas Medical CenterCharlotte, NC, USA

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Endoscopic surgery forpancreaticobiliary cancer

Introduction

Pancreatic and extrahepatic biliary cancers are extremelyaggressive tumors with a poor prognosis. Biological char-acteristics of this cancer create the need to achieve a balancein surgical treatment between operative agressiveness forcure and a low morbidity for palliative care. Unfortunately,this balance is easily lost: Many patients are not offered asurgical option based on the morbidity of standard laparot-omy and the presumed (not always true) hopelessness of thediagnosis, or they are subjected to the morbidity of a lapa-rotomy only to, not infrequently, find contraindications tocurative resection. In the latter case, palliative bypass is theonly potential benefit that can be offered to the patient dur-ing the laparotomy, but this palliation is compromised bythe pain and long recovery from the surgery. As in so manyother fields in gastrointestinal surgery, endoscopic proce-dures, both flexible and laparoscopic, are playing an in-creasing role in achieving a balance between the ‘‘cruelcure’’ and the ‘‘kind palliation.’’

Staging

Diagnostic laparoscopy has been identified as an importanttool in the accurate staging and determination of resectabil-ity in pancreatic and biliary cancers. This has been demon-strated by numerous investigators since the mid-70s withthe primary benefit being the identification of small perito-neal metastases undetectable by radiologic imaging modali-ties. The low sophistication of ancillary instruments initiallyconfined laparoscopy to a simple peritoneal survey andtherefore the accuracy rate for determining resectability wassomewhat low (60%). In the 1990s the use of laparoscopyfor increasingly sophisticated surgeries gave pancreatic sur-geons the tools needed to do a full exploration of the upperabdomen including the lesser sac and retroperitoneum andtherefore markedly improved the diagnostic and staging ac-curacy rates for this modality. The recent addition of lapa-roscopic ultrasonography has further increased the useful-ness of this approach with staging accuracy rates now beingreported in the 90% range. Investigators who routinely uselaparoscopy in conjunction with other imaging techniquescan now with a high degree of accuracy (greater than 75%)avoid unneeded laparotomies which would only determinethe patient was in fact unresectable.

Similar advances in the technology of flexible endos-copy have also provided low-morbidity diagnostic capabili-ties as well. In particular, the use of endoscopic ultrasoundhas been shown to be highly accurate in determining inva-sion of the portal vein, the second most common reason forunresectability. This has resulted in a much lower morbiditythan traditional angiography and allows the subsequent per-formance of flexible endoscopic palliation should that needexist.

Palliation

A substantial number of patients with pancreatobiliary can-cers will eventually suffer biliary obstruction (75%) or

gastric outlet obstruction (21%) before their death. Thismarkedly contributes to their discomfort and morbidity andcertainly justifies palliative intervention. The use of endo-scopically placed retrograde stents, and more recently ex-panded metal stents, offers a very minimally invasive pal-liation for malignant bile duct strictures. Unfortunately, thesame is not true for gastric outlet obstruction, which wouldobviate flexible endoscopy for either approach. Flexible en-doscopy also is not always successful and is not without itsown associated risks and morbidity, which may be poorlytolerated in this patient group. Another drawback with theuse of stents is their short life span (6–12 weeks) necessi-tating returns to the hospital for exchanges, often when thepatients are at their very sickest terminal state. Since sur-gery, either open or laparoscopic, remains the gold standardfor the accurate staging of patients, a single procedure toboth staging and palliation is certainly a desirable goal.While gastrojejunostomy and cholecystoenterostomy orcholedochoenterostomy are well-tolerated and effectivemeans of achieving bypass and decompression, there aresome patients who are not candidates. These include pa-tients with such extensive tumor that the extrahepatic biliarytract is not accessible and those who have had previousbiliary or gastric surgeries. The literature indicates that only22–58% of patients with malignant bile duct obstruction and75% of gastric outlet obstruction meet the criteria for effec-tive palliative bypass.

Certainly if these bypasses can be achieved with lapa-roscopic means, effective palliation is accomplished whilethe morbidity and prolonged hospital stay of open laparot-omy are avoided. The introduction of endoscopic staplingdevices and the overall improvement and advancement ofsurgeon’s skills in the realm of suturing have made proce-dures such as cholecystojejunostomy and gastrojejunostomyquite feasible. More recently, choledochojejunostomy hasbeen defined in animal models and may further broaden therepertoire of laparoscopic surgical bypass.

Additional reports defining combinations of flexible en-doscopy, laparoscopy, and even interventional radiology arebeginning to appear. All of these can be considered mini-mally invasive endoscopic approaches to pancreatobiliarycancer which allow accurate staging, better determination ofresectability, and an effective low-morbidity palliation forthese unfortunate patients.

Selected readings

Cuschieri A, Hall AW, Clark J (1978) Value of laparoscopy in the diag-nosis and management of pancreatic cancer. Gut 19: 672

Huibregtse K, Carr LD, Cremer M, et al. (1992) Biliary stent occlusion—aproblem solved with self-expanding metal stents? European WallstentStudy Group. Endoscopy. 24(5): 391–394

John TG, Garden OJ (1993) Assessment of pancreatic cancer. In: CuestaMA, Nagy AG (eds). Minimally invasive surgery in gastrointestinalcancer. New York: Churchill Livingstone, pp 95–111

Rosch T, Braig C, Gain T, et al. (1992) Staging of pancreatic and ampul-lary carcinoma by endoscopic ultrasonography. Gastroenterology 102:188

Schob OM, Schlumpf R, Schmid R, et al. (1995) Laparoscopic treatment ofbiliary and gastric outlet obstruction. Surg Laparosc Endosc 5(4): 288–295

Schob OM, Schmid R, Morimoto A, et al. (1997) Laparoscopic Roux-en-Ycholedochojejunostomy. Am J Surg 173(4): 312–319

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Shimi S, Banting S, Cuschieri A (1992) Laparoscopy in the management ofpancreatic cancer: endoscopic cholecystojejunostomy for advanced dis-ease. Br J Surg 79(4): 317–319

Singh SM, Longmire WP, Reber HA (1990) Surgical palliation for pan-creatic cancer—the UCLA experience. Ann Surg 212:132–139

Soulez G, Gagner M, Therasse E, et al. (1994) Malignant biliary obstruc-tion: preliminary results of palliative treatment with hepaticogastros-tomy under fluoroscopic, endoscopic, and laparoscopic guidance. Ra-diology 192: 241–246

Tarnasky PR, England RE, Lail LM, et al. (1995) Cystic duct patency inmalignant obstructive jaundice. Ann Surg 221(3): 265–271

Warshaw AL, Pepper JB, Shipley AW (1986) Laparoscopy in the stagingand planning of therapy for pancreatic cancer. Am J Surg 151: 76

Warshaw AL, Gu Z-Y, Wittenberg J, et al. (1990) Preoperative staging andassessment of resectability of pancreatic cancer. Arch Surg 125: 230

Lee L. Swanstrom

Department of SurgeryOregon Health Sciences UniversityPortland, OR, USA

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Laparoscopic surgery forsolid lesionsDiagnostic and therapeutic procedures for the liver can nowbe done via an open, laparoscopic, laparoscopic assisted,percutaneous, or transvascular approach. Standard surgicalinstrumentation has improved (sutures, clips, cautery, he-mostatic agents) and has been adapted for laparoscopic use(cryoablation, argon coagulator, endostaplers, echodoppler,injection). New technologies have been developed (hydro-jet, the harmonic scalpel, microwave coagulation). The in-creasing expertise in advanced laparoscopy and continuedtechnological advances are likely to provide the basis forexpanding the use of laparoscopic procedures on the liver.

Requirements for laparoscopic liver surgery are exper-tise in open liver surgery, expertise in two-handed laparos-copy, knowledge of laparoscopic instrumentation and tech-nology, thorough understanding of the underlying diseaseand its biology, and knowledge of the alternative therapiesavailable.

Laparoscopic liver surgery has been used for diagnosis,biopsy and staging resections (anatomic and nonanatomic),enucleation, cryoablation, injection, coagulation and arterialcatheter implantation. Nevertheless, the experience is stilllimited. For example, my personal series of resections islimited to nine cases. For this reason, we surveyed othergroups through a questionnaire and personal communica-tion. Data was obtained from Hotel-Dieu, Montreal (GagnerM., Pomp A.); Creighton University, Nebraska (FitzgibbonsR.); Washington University, Seattle (Pellegrini C., HeltonS.); Mayo Clinic (Nagorney D.); Rush University, Chicago(Deziel D., Prinz R.C.); Emory University, Atlanta (HunterJ., Galloway, Branum E.); and Lahey Clinic, Boston (RossiR., Tsao J.).

The experience with adenomas and nodular hyperplasiawas 19 cases with a median size of 6 cm. Two were treatedby enucleation, 11 by nonanatomic resections, and six wereonly biopsied. The lesions were in anterior hepatic loca-tions. Resective procedures took about 2 h to perform.There was bleeding in one case but none required conver-sion.

Fifteen cases of hepatic hemangiomas were treated butonly the Hotel Dieu and Lahey Clinic group managed le-sions larger than 6 cm. The four largest hemangiomas weresymptomatic. One was enucleated and three were treated bynonanatomic resections. There was no bleeding or need forconversion. The operations for two patients with hemangi-omas over 6 cm were completed within 2 h.

The data on primary hepatic tumors included 27 cases.Of these, 18 were biopsied and staged, two resected (oneanatomic, one nonanatomic), three treated with alcohol in-jection, and one treated with cryoablation. There were twoconversions, one for bleeding and one (Lahey Clinic case of8 cm) because the right-sided lesion, thought initially to bebenign preoperatively, was suspected during dissection tobe malignant, favoring an open resective oncologic proce-dure.

Information on 143 cases of metastatic disease to theliver was received. Biopsy and staging only was done in 113cases. Nonanatomic resections were done in 19 cases, ana-tomic resection in one, cryoablation in ten, and alcohol in-

jection in three. There was one conversion for bleeding andone for a bile leak after cryoablation.

The Lahey Clinic experience with three presumed cyst-adenomas is of interest. Two were enucleated successfully(6 and 12 cm) and confirmed histologically. However, thethird case (4 cm) was felt during dissection to not be atypical cystadenoma. The procedure was converted; anonanatomic resection was done; the final diagnosis wasneurosarcoma with central necrosis.

The majority of lesions were removed in plastic bagsthrough enlarged umbilical incisions. However, other routesincluded minilaparotomies and colpotomy.

Reports on laparoscopic resections are few. Kaneko etal. reported on 11 patients done with gasless laparoscopy.Six had nonanatomic resections and three left lateral seg-mentectomies. The indications were metastatic disease inthree, hepatocellular carcinoma in four, hemangiomas intwo, and others in two. Instruments used included endosta-plers, microwave coagulation, ultrasonic dissector and theargon beam coagulator. The locations of the lesions weresegment 2, or 2 and 3 in four cases, segment 4 in one case,segment 5 in one case, and segment 6 in two cases. One caserequired conversion for bleeding. Gugenheim et al. havereported on three successful nonanatomic resections for le-sions of 4 cm or more in size, allowing earlier hospitaldischarge.

Yamanaka et al., comparing microwave coagulation ne-crosis with open wedge resection for hepatocellular carci-noma, show that the former procedure can be performed ina shorter time, with less complications, minimal blood loss,and with similar survival as the latter, raising again thepossible advantages of laparoscopic ‘‘tumor destructivetechniques.’’ There is preliminary data that suggest advan-tages of the multimodal water jet dissector over the ultra-sonic dissector. Cushieri et al. have developed a high-efficiency cryosurgical unit with multiple probes. Laparo-scopic-assisted techniques are being used for lesions in lessaccessible locations (segments 7, 8).

Feliciotti et al. have reported on three cases of catheterimplantation for arterial infusion using the gastroduodenalartery.

Complications of laparoscopic liver surgery include gasembolism (from CO2 or argon), the possibility of incom-plete tumor removal or destruction, bleeding, bile leak, andthe possibility of tumor spread.

In conclusion, we are in the early stages of evolvinglaparoscopic liver techniques, whose use is likely to in-crease. The merits and limitations of this approach com-pared to other treatments need further and continued evalu-ation. Those who become involved need expertise in opensurgery and thorough knowledge of the underlying diseaseand of the alternative therapies. Laparoscopic techniques aregood for diagnosis, staging and biopsy, especially if asso-ciated with endoscopic ultrasound. Based on experiences todate, laparoscopic procedures may be increasingly used forbenign superficial lesions and selectively, for malignant tu-mors (resection, cryoablation, coagulation, injection, etc.).Destructive tumor techniques, if proven as effective as re-section for certain lesions, could provide additional stimulusfor a laparoscopic approach. It is suggested that S.S.A.T.and SAGES sponsor a database for laparoscopic liver cases.

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Selected readings

Cushieri A, Crostwaite G, Shimi S, et al. (1995) Hepatic cryotherapy forliver tumors. Surg Endosc 9: 483–489

Feliciotti F, Paganini A, Guerrier M, et al. (1996) Laparoscopic intraarte-rial catheter implantation. Surg Endosc 10: 449–452

Gugenheim J, Mazza D, Katkouda B, et al. (1996) Laparoscopic resectionof solid liver tumors. Br J Surg 83: 334–335

Kaneko H, Takagi S, Shiba T (1996) Laparoscopic partial hepatectomy andleft lateral segmentectomy. Surgery 120: 468–475

Rau HG, Meyer G, Jauch KW, et al. (1996) Liver ‘‘resection’’ with thewater jet. Chirurg 67: 546–551

Yamanaka N, Tanaka T, Oriyama T, et al. (1996) Microwave coagulone-crotic therapy for hepatocellular carcinoma. World J Surg 20: 1076–1081

Ricardo Rossi

Facultad de MedicinaPontificia UniversidadCatolica De ChilaSantiago, Chile

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SAGES position statement on advanced laparoscopic training

The Society of American Gastrointestinal Endoscopic Sur-geons (SAGES) endorses the following concepts for train-ing in laparoscopic surgery.

1. Laparoscopic operations comprise a core component ofgeneral surgery.

2. Training of general surgeons in laparoscopic surgeryshould occur within the five-year general surgery resi-dency.

3. General surgical training should include a defined num-ber of basic* laparoscopic operations.

4. Advanced laparoscopic operations† are a scarce com-modity in most general surgical residency programs. Ad-

vanced laparoscopic operations should not, at this time,be designated as a defined category.

5. Program directors should be granted the flexibility tofocus the residency experience in advanced laparoscopicsurgery on those individuals who are committed to acareer in general surgery.

This document was reviewed and approved by the Board of Governors ofthe Society of American Gastrointestinal Endoscopic Surgeons (SAGES),March, 1997. It was prepared by an ad hoc task force on Residency Inte-gration.

Society of American Gastrointestinal EndoscopicSurgeons (SAGES)

2716 Ocean Park Boulevard, Suite 3000Santa Monica, CA 90405, USA

*Basic laparoscopic surgery is comprised of diagnostic laparoscopy, lap-aroscopic cholecystectomy, and laparoscopic appendectomy.†Advanced laparoscopic surgery consists of all other laparoscopic opera-tions.

Surg Endosc (1998) 12: 377

© Springer-Verlag New York Inc. 1998

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SAGES position papers

Integrating advanced laparoscopy into surgical residency training

Introduction

Laparoscopic operations are a primary component of gen-eral surgery. The Society of American Gastrointestinal En-doscopic Surgeons (SAGES) is dedicated to the advance-ment of training in minimal access surgery to assure the safeperformance of such operations. The purpose of this docu-ment is to further the integration of advanced laparoscopicsurgical training into the curriculum of the general surgeryresidency. Opportunities to perform laparoscopic operationscurrently vary widely between surgical training programs.The proposals presented in this document are intended ascurrent measures to improve training opportunities in a dy-namic environment. As utilization of minimal access pro-cedures increases in the future, residents will more readilylearn the skills necessary to accomplish these operationssafely. In that setting, the proposals below may no longer benecessary.

Curriculum guidelines in advanced laparoscopic surgery

Basic laparoscopic operations include laparoscopic chole-cystectomy, laparoscopic appendectomy, and diagnosticlaparoscopy. All other laparoscopic operations are definedas advanced. Prior to learning or performing advanced lap-aroscopic operations, the resident must be familiar with andexperienced in basic laparoscopy.

Laparoscopic operations, as with all operations, are ap-propriately learned in the broad context of surgical scienceand practice. Critical educational components include:pathophysiology of disease, diagnosis, operative indicationsand contraindications, familiarity with alternative treat-ments, comprehensive principles of pre- and postoperativecare, and understanding of the prevention, diagnosis, andtreatment of complications. In addition, the relative advan-tages and disadvantages of both open and minimal accessapproaches must be known.

SAGES ‘‘Curriculum Guideline for Resident Educationin GI Surgical Endoscopy, Laparoscopy, and Thoracos-copy’’ contains an outline of knowledge and skills to bemastered in basic and advanced laparoscopy.

Skills acquisition for advanced laparoscopic operations

Training to learn advanced laparoscopic operations beginswith acquisition of skills in basic laparoscopy. There is a

core group of technical skills common to all advanced lap-aroscopic operations. Such skills are best acquired in theoperating room or, alternatively, through skills laboratoriesinvolving surgical trainers, animal models, or other simu-lated operating conditions. Examples of such skills includetwo-handed dissection, intracorporeal suturing, and intra-and extracorporeal knot tying. Mastery of these advancedlaparoscopic skills by the resident is encouraged prior toinitiating an experience performing advanced laparoscopicoperations. Experience in the performance of a specific op-eration via celiotomy will also facilitate mastery of the simi-lar laparoscopic procedure using a minimal access ap-proach.

Since many advanced laparoscopic skills are common toall advanced laparoscopic operations, experience in a spe-cific operation enhances the acquisition of skills necessaryto perform others. Therefore, it is the combined experiencein advanced procedures that should be emphasized duringtraining, rather than the mastery of any one individual pro-cedure.

Methods to integrate advanced laparoscopy traininginto general surgery residency

SAGES’ long-term goal is to facilitate complete integrationof advanced laparoscopic training within each surgical pro-gram. Residents should ultimately learn these procedures inthe operating room under the direction of skilled facultyinstructors. Until such time as complete integration is pos-sible, SAGES belies the following measures can help ac-complish this goal:

● Train faculty● Train residents● Provide guidelines for postresidency training for prospec-

tive faculty

I. Basic laparoscopic surgery

Most programs provide adequate experience in basic lapa-roscopic surgery. To assure ongoing availability of basictraining resources, the following is recommended:

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Basic laparoscopy courses for residents

SAGES plans to continue offering existing SAGES coursesin basic laparoscopic surgery. These courses, offered twiceyearly, are two-day courses for residents focusing on thebasic principles and skills of endoscopic and laparoscopicsurgery. A total of approximately 120 residents are enrolledin these courses yearly, which represents approximately12% of the annual number of graduating residents.

Basic laparoscopy courses for faculty

When laparoscopy for general surgery was introduced,SAGES organized a series of ‘‘training the trainers’’courses, which provide on-site faculty training at 17 insti-tutions. This intensive training provided a mechanism totrain more than 250 surgical faculty. The need for trainingin basic laparoscopy has diminished. However, if a need forfaculty training in basic laparoscopy still exists, SAGESwill endeavor to provide a similar type of training.

II. Advanced laparoscopic surgery

A. Faculty training1. Courses: ‘‘Hands-on’’ courses are useful for con-

veying the techniques of laparoscopic operations tothose who are proficient in the similar open opera-tions. Faculty members interested in obtaining ad-vanced laparoscopic training may benefit from ad-vanced laparoscopic courses. SAGEs will providean opportunity for faculty members to participate inadvanced laparoscopic surgical courses. See SectionB1.

2. Faculty mentoring: SAGES believes that facultywho have already acquired the fundamental skills inadvanced laparoscopic surgery and who desire tolearn a new or modified laparoscopic operation, willbenefit from observing and interacting with a peerwho is skilled and accomplished in that specific op-eration. SAGES will facilitate this process by devel-oping a list of mentoring opportunities available forspecific laparoscopic operations.

3. Fellowships:Postgraduate training in advanced lap-aroscopic surgery is another means by which facultyor faculty candidates may obtain experience. Suchprograms should not detract from the experience ofthe surgical residency training where they coexist.SAGES believes the main goal of such fellowshipsshould be to train future faculty.

B. Resident training1. Courses: Courses in advanced laparoscopic proce-

dures are one method of introducing skills. SAGESplans to offer ongoing courses for residents and,when necessary, an accompanying faculty member,for a laboratory experience in advanced laparoscopicsurgery.

Appropriate candidates for such courses are:● residents who plan a career in general surgery● residents who have already achieved a mastery ofbasic laparoscopic surgery● residents who are unlikely, based on their pro-gram’s current practice patterns, to obtain a signifi-cant experience in advanced laparoscopic surgicaltechniques.● faculty from programs who do not have faculty toteach the procedure in question may elect to send afaculty member to the course.

2. Skills labs: The creation of inanimate and animaltraining facilities by individual programs is encour-aged to provide supplemental teaching of advancedlaparoscopic surgical skills. SAGES will facilitatethe acquisition of or access to advanced laparoscopicequipment and skills lab facilities. Additionally,SAGES plans to organize regional skills labs [1].

3. Needs assessment:SAGES will continue to assessthe needs of residency programs both in terms offaculty training and overall program needs.

4. Re-examination of residency training: Optimaltraining in a general surgery residency includes anadequate experience in both advanced open and lap-aroscopic procedures. Data suggest that case load isinsufficient to produce such an experience. SAGESsuggests that the appropriate leadership organiza-tions consider re-examining the flexibility of thegeneral surgery residency training in order to opti-mize the availability of such advanced cases for resi-dents planning a career in general surgery.

5. Educational resources:SAGES will continue to of-fer other educational endeavors such as postgraduatecourses, annual meetings, an extensive video library,a syllabus on topics in endoscopic and laparoscopicsurgery for residents, a curriculum guideline forresidency training in endoscopic and laparoscopicsurgery, guidelines for credentialing, training, andstandards of practice. A separate candidate member-ship category exists for residents and fellows.

Summary

SAGES was founded to further the advancement of sur-geons performing gastrointestinal endoscopy. In part due tothe society’s previous efforts, training in flexible endoscopyis now recognized as a mandatory component of training ingeneral surgery. SAGES has more recently promoted thesafe practice of laparoscopic surgery, which since 1991 hasevolved to be a standard component of the practice of mostgeneral surgeons. Consistent with the goal of continuing toprovide the public with surgeons competent in performingall varieties of appropriate laparoscopic procedures, SAGESjoins other major surgical organizations in addressing theconcern that, while basic laparoscopic procedures are mas-tered during residency training in general surgery, advancedprocedures and the skills required to initiate safely an ex-perience in them often are not.

Incorporation of advanced laparoscopic surgical skillsinto surgical residency and the safe incorporation and per-

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formance of advanced laparoscopic operations into surgicalpractice are dynamic processes. With the above proposals,SAGES hopes to facilitate both processes. We have, herein,set forth suggested curriculum guidelines for resident train-ing in laparoscopic surgery. We have outlined measures bywhich resident and faculty training in advanced laparoscop-ic surgical skills may be realized. Focusing on adequatelytraining the trainers is essential in order to facilitate resi-dency training in the future. As practice patterns evolve andthe frequency of laparoscopic operations increases, the op-portunities for residents to learn required skills will in-crease. As a result, they will be able to accomplish safelysuch procedures. In that setting, the proposed special effortsoutlined above may no longer be necessary.

References

1. Society of American Gastrointestinal Endoscopic Surgeons (SAGES)(1994) Framework for postresidency surgical education and training–aSAGES guideline. Surg Endosc 8: 1137–1142

This document was reviewed and approved by the Board of Governors ofthe Society of American Gastrointestinal Endoscopic Surgeons (SAGES),March, 1997. It was prepared by an ad hoc task force on residency inte-gration.

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SAGES statement on concentration in general surgery residency

The SAGES document entitled ‘‘Integrating Advanced Lap-aroscopy into Surgical Residency Training’’ and the com-panion position statement outline the Society’s position ontraining in advanced laparoscopic surgery.

To achieve the goals set forth in the document, SAGESrecommends that surgical training programs adopt a policythat assures acquisition of advanced laparoscopic skills dur-ing residency training. Those surgeons-in-training who planto practice the speciality of general surgery should be givenpreferential opportunity to apply those skills through spe-

cific operative experience at an appropriate time in theirresidency.

Adopted by SAGES Executive Committee, August, 1997. Approved bySAGES Board of Governors, October, 1997.

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Granting of privileges for gastrointestinal endoscopy by surgeons

I. Principles of Credentialing

Preamble

This document is to serve as a guide for granting privilegesin gastrointestinal endoscopy as an integral part of surgicalpractice. Surgeons who are experienced in operating on thegastrointestinal tract are familiar with anatomy, tissue tol-erance, organ compliance, and pathological processes, andshould readily develop endoscopic proficiency whichshould be assessed independent of the number of proceduresperformed.

A. Purpose

The purpose of this statement is to outline principles and toprovide practical suggestions to assist hospital credentialingcommittees in the task of granting privileges to performgastrointestinal endoscopy. In conjunction with the standardJCAHO guidelines for granting hospital privileges, imple-mentation of these methods should help hospital staffs in-sure that endoscopy is performed only by individuals withappropriate competency, thus assuring high quality patientcare and proper procedure utilization.

B. Uniformity of standards

Uniform standards should be developed, which apply to allhospital staff requesting privileges to perform endoscopy,and to all areas where endoscopy is performed within agiven institution. Criteria must be established that are medi-cally sound, not unreasonably stringent, and that are appli-cable in common to all those wishing to obtain privileges ineach specific endoscopic procedure. The goal must be thedelivery of high quality patient care.

C. Specificity of credentialing

Privileges should be granted for each major category ofendoscopy separately. The ability to perform one endo-scopic procedure does not imply adequate competency toperform another. Associated skills that are generally con-sidered to be an integral part of an endoscopic category maybe required before privileges for that category can begranted.

D. Responsibility for credentialing

The credentialing structure and process remains always theindividual responsibility of each hospital. It should be theresponsibility of the Department of Surgery, through its

chief, to recommend individual surgeons for privileges ingastrointestinal endoscopy as for other procedures per-formed by members of his or her department.

II. Training and determination of competence

A. Formal residency training in gastroenterologyor surgery

The Accreditation Council for Graduate Medical Educationmandated that: ‘‘The program must provide experience toeach resident in the performance of a variety of rigid andflexible endoscopic procedures, including laryngoscopy,bronchoscopy, esophagoscopy, gastroscopy, colonoscopy,diagnostic and therapeutic laparoscopy, and intraoperativecholedochoscopy, as well as the study and performance ofnew and evolving endoscopic techniques’’ (Directory ofResidency Training Programs, Graduate Medical EducationDirectory 1997–1998).

B. Endoscopic training and experience outside a formalresidency program

Equivalent training and/or experience obtained outside aformal program is recognized, but must be at least equal tothat described above. Certification of experience by askilled endoscopic practitioner must include a detailed de-scription of the nature of ‘‘informal’’ training, the numberof procedures performed with and without supervision, andthe actual observed competency of the applicant for eachendoscopic procedure for which privileges are requested. Itis generally no longer acceptable for physicians to acquireequivalent endoscopic experience by performing unsuper-vised procedures when skilled endoscopists are available inthe medical community.

C. Determination of Competence

1. Completion of a surgical residency program which in-corporates structured experience in gastrointestinal en-doscopy. Competence should be documented by the in-structor(s).

2. Proficiency in endoscopic procedure(s) and clinicaljudgment equivalent to that obtained in a residency pro-gram. Documentation and demonstration of competenceis necessary.

3. Participation in gastrointestinal endoscopic training untilcompetence in the specific procedure(s) is equivalentto 1.

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4. The applicant’s endoscopic director should confirm inwriting the training, experience (including the number ofcases for each procedure for which privileges are re-quested), and actually observed level of competency. It isrecognized that by virtue of completing a residency pro-gram in surgery, the surgeon endoscopist will have ac-quired at least five years of cognitive experience inanatomy, physiology, disease process, combined withthe progressive development of visual and psychomotorskills, and the experience necessary for the performanceof diagnostic and therapeutic procedures in the gastroin-testinal tract. Such experience includes indications, com-plications and their management, and alternative ap-proaches. It is recommended that the performance of atleast 25 esophagogastroduodenoscopies, 50 colonosco-pies, or 25 flexible sigmoidoscopies serve as minimalrequirements for consideration of competence (in thespecific procedure) in addition to the above trainingbackground. The training director’s opinion and recom-mendation should be consideredprima facie evidencefor the trainee’s acceptance as an individual qualified ingastrointestinal endoscopy. Likewise, attendance at shortendoscopy courses, which do not provide supervised,hands-on training with patients, is not an acceptable sub-stitute in the development of equivalent competency.

D. New Procedures

Self training in new techniques in gastrointestinal endos-copy must take place on a background of basic surgical andendoscopic skills. The endoscopist should recognize whenadditional training is necessary.

E. Proctoring

Recognizing the limitations of written reports, proctoring ofapplicants for privileges in gastrointestinal endoscopy by aqualified, unbiased staff endoscopist may be desirable, es-pecially when competency for a given procedure cannot beadequately verified by submitted written material. The pro-cedural details of proctoring should be developed by thecredentialing body of the hospital and provided to the ap-plicant. Proctors may be chosen from existing endoscopystaff or solicited from endoscopic societies. The proctorshould be responsible to the credentials committee, and notto the patient or to the individual being proctored. Docu-mentation of the proctor’s evaluation should be submitted inwriting to the credentials committee. Criteria of competencyfor each procedure should be established in advance. It isessential that proctoring be provided in an unbiased, confi-dential, and objective manner. A satisfactory mechanism forappeal must be established for individuals for whom privi-leges are denied or granted in a temporary or provisionalmanner.

F. Monitoring of endoscopic performance

To assist the hospital credentialing body in the ongoingrenewal of privileges, there should be a mechanism formonitoring each surgical endoscopist’s procedural perfor-

mance. This should be done through existing quality assur-ance mechanisms or, alternatively, through a multidisci-plinary endoscopy committee. This should include monitor-ing endoscopic utilization, diagnostic and therapeuticbenefits to patients, complications, and tissue review in ac-cordance with previously developed criteria.

G. Continuing education

Continuing medical education related to endoscopy shouldbe required as part of the periodic renewal of endoscopicprivileges. Attendance at appropriate local, national, or in-ternational meetings and courses is encouraged.

H. The renewal of privileges

For the renewal of privileges, an appropriate level of con-tinuing clinical activity should be required, in addition tosatisfactory performance as assessed by monitoring of pro-cedural activity through existing quality assurance mecha-nisms, as well as continuing medical education relating togastrointestinal endoscopy.

References1. Anderson ML, Heigh RI, McCoy GA, Parent K, Muhm JR, McKee

GS, Eversman WG, Collins JM (1992) Accuracy of assessment of theextent of examination by experienced colonoscopists. Gastrointest En-dosc 38: 560–563

2. Barthel J, Hinojosa T, Shah, N (1995) Colonoscope length and pro-cedure efficiency. J Clin Gastroenterol 21: 30–32

3. Chak A, Cooper GS, Blades EW, Canto M, Sivak MV Jr (1996)Prospective assessment of colonoscopic intubation skills in trainees.Gastrointest Endosc 44: 54–57

4. Church JM (1994) Complete colonoscopy: how often? And if not, whynot? Am J Gastroenterol 89: 556–560

5. Cosgrove JM, Cohen JR, Wait RB, Margolis IB (1995) Endoscopytraining during general surgery residency. Surg Laparosc Endosc 5:393–395

6. Galandiuk S (1995) A surgical subspecialist enhances general surgicaloperative experience. Arch Surg 130: 1136–1138

7. Gruber M (1996) Performance of flexible sigmoidoscopy by a clinicalnurse specialist. Gastroenterol Nurs 19: 105–108

8. Hasseman JH, Lemmel GT, Emad RY, Douglas RK (1997) Failure ofcolonoscopy to detect colorectal cancer: evaluation of 47 cases in 20hospitals. Gastrointest Endosc 45: 451–455

9. Jentschura D, Raute M, Winter J, Henkel Th, Kraus M, Manegold BC(1994) Complications in endoscopy of the lower gastrointestinal tract(therapy and prognosis). Surg Endosc 8: 672–676

10. Marshall B (1995) Technical proficiency of trainees performing colo-noscopy: a learning curve. Gastrointest Endosc 42: 287–291

11. Parry BR, Williams SM (1991) Competency and the colonoscopist: alearning curve. Australia/New Zealand J Surg 61: 419–422

12. Rai S, Moran MR, Rai AM (May 1996) Colon and rectal cancer:epidemiology and investigation, are colonoscopies performed by sub-specialists more expensive? Dis Colon Rectum 39

13. Saad JA, Pirie P, Sprafka JM (1994) Relationships between flexiblesigmoidoscopy training during residency and subsequent sigmoidos-copy performance in practice. Family Med 26: 250–253

This statement was reviewed and approved by the Board of Governorsof the Society of American Gastrointestinal Endoscopic Surgeons(SAGES), May, 1997. It was prepared by the SAGES Committee on Cre-dentialing.

This is a revision of SAGES Publication #004 originally printed 10/89and of SAGES Publication #0011 printed 1/92.

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SAGES guidelines

Guidelines for granting of privileges for laparoscopic and/orthoracoscopic general surgery

I. Principles of privileging

Preamble

The Society of American Gastrointestinal Endoscopic Sur-geons (SAGES) recommends the following guidelines forprivileging qualified surgeons in the performance of generalsurgical procedures utilizing laparoscopy and/or thoracos-copy. The basic premise is that the surgeon must have thejudgment, training, and capability of immediately proceed-ing to a traditional open thoracic or abdominal procedurewhen circumstances so indicate.

This document is to serve as a guide for granting privi-leges in laparoscopic and/or thoracoscopic surgery as anintegral part of surgical practice. Surgeons who are experi-enced in operating in the abdomen and/or chest are familiarwith anatomy, tissue tolerance, organ compliance, andpathological processes, and should readily develop laparo-scopic and/or thoracoscopic proficiency, which should beassessed regardless of the number of procedures performed.

A. Purpose

The purpose of this statement is to outline principles andprovide practical suggestions to assist hospital privilegingcommittees when granting privileges to perform laparo-scopic and/or thoracoscopic surgery. In conjunction withthe standard JCAHO guidelines for granting hospital privi-leges, implementation of these methods should help hospitalstaffs ensure that laparoscopic and/or thoracoscopic surgeryis performed only by individuals with appropriate compe-tence, thus assuring high quality patient care and properprocedure utilization.

B. Uniformity of standards

Uniform standards should be developed, which apply to allhospital staff requesting privileges to perform laparoscopicand/or thoracoscopic general surgery. Criteria must be es-tablished which are medically sound but not unreasonablystringent, and which are universally applicable to all thosewishing to obtain privileges. The goal must be the deliveryof high-quality patient care.

C. Responsibility for privileging

The privileging structure and process remain the individualresponsibility of each hospital. It should be the responsibil-ity of the Department of Surgery, through its Chief, to rec-ommend individual surgeons for privileges in laparoscopicand/or thoracoscopic general surgery as for other proce-dures performed by members of the department.

II. Training and determination of competence

A. Formal residency training in general and/orthoracic surgery

Prerequisite training must include satisfactory completionwith Board eligibility or certification from residency pro-grams in general and/or thoracic surgery accredited by theAccreditation Council for Graduate Medical Education orthe equivalent body if the program is based outside theUnited States or Canada.

B. Determination of competence in laparoscopic and/orthoracoscopic surgery

1. A surgical residency program, which incorporates struc-tured experience in laparoscopic and/or thoracoscopicgeneral surgery, should be completed. The applicant’sProgram Director should confirm in writing the training,experience, and actual observed level of competency,which could include case lists, as is done for other pro-cedures in surgery.

2. The surgeon should demonstrate proficiency in laparo-scopic and/or thoracic surgical procedures and clinicaljudgment equivalent to that obtained in a residency pro-gram. The requirements for documentation and demon-stration of competence is determined by the appropriatecredentialing and qualifications committee.

3. For those surgeons without residency training, which in-cluded laparoscopic and/or thoracoscopic surgery, orwithout documented prior experience in these areas, thetraining should include didactics, hands-on experience,participation as a first assistant, and performance of theoperation under proctorship. The basic minimum re-quirements for training should be:a. completion of approved residency training in general

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and/or thoracic surgery, with privileging in the com-parable open procedure for which laparoscopic and/orthoracoscopic privileges are being sought,

b. training in laparoscopic general and/or thoracoscopicsurgery by a surgeon experienced in laparoscopic/thoracoscopic surgery or completion of a didacticcourse sponsored by an institution or society accred-ited by ACCME. Such a course should include in-struction in handling and use of laparoscopic and/orthoracoscopic instrumentation, establishment of safeperitoneal and/or thoracic access, tissue handling,knot tying, equipment utilization, as well as hands-onexperience in specific categories of procedures forwhich the applicant desires privileges. The individualmust demonstrate to the satisfaction of an experiencedphysician course director/preceptor that he/she canperform a given procedure from beginning to end.Such proficiency for each category of procedure inquestion must be documented in writing by the phy-sician course director. The course content and proce-dures taught should clearly include material specificto the category of procedure for which privileges aresought. Attendance at short courses that do not pro-vide supervised hands-on training or documentationof proficiency is not an acceptable substitute,

c. proctoring by a laparoscopic and/or thoracoscopicsurgeon experienced in the same or similar proce-dure(s) until proficiency has been observed and docu-mented in writing.

C. Proctoring

Recognizing the limitations of written reports, proctoring ofapplicants for privileges in laparoscopic and/or thoraco-scopic surgery by a qualified, unbiased staff surgeon expe-rienced in general and/or thoracic and laparoscopic and/orthoracoscopic surgery is recommended. The procedural de-tails of proctoring should be developed by the privilegingbody of the hospital and provided to the applicant. Proctorsmay be chosen from existing staff or solicited from surgicalendoscopic societies. The proctor should be responsible tothe privileging committee, and not to the patient or to theindividual being proctored. Documentation of the proctor’sevaluation should be submitted in writing to the privilegingcommittee. Criteria of competency for each procedureshould be established in advance and should include evalu-ation of: familiarity with instrumentation and equipment,competence in their use, appropriateness of patient selec-tion, clarity of dissection, safety, time taken to complete theprocedure and successful completion of same. It is essentialthat proctoring be provided in unbiased, confidential, andobjective manner. A satisfactory mechanism for appealmust be established for individuals for whom privileges aredenied or granted in a temporary or provisional manner.

D. Monitoring of laparoscopic and/orthoracoscopic performance

To assist the hospital privileging body in the ongoing re-newal of privileges, there should be a mechanism for moni-

toring competence. This should be done through existingquality assurance mechanisms. This should include moni-toring utilization, diagnostic and therapeutic benefits to pa-tients, complications, and tissue review in accordance withpreviously developed criteria.

E. Continuing education

Continuing medical education related to laparoscopic and/orthoracoscopic surgery should be required as part of the pe-riodic renewal of privileges. Attendance at appropriate lo-cal, national, or international meetings and courses is en-couraged.

F. Renewal of privileges

For the renewal of privileges, an appropriate level of con-tinuing clinical activity should be required. In addition tosatisfactory performance as assessed by monitoring of pro-cedural activity through existing quality assurance mecha-nisms, continuing medical education relating to laparoscop-ic and/or thoracoscopic surgery should also be required.

References

1. Dent TL (March 1991) Clinical privileges for laparoscopic generalsurgery. Am J Surg 161: 399–403

2. E.A.E.S. Guidelines (1994) Training and assessment of Competence.Surg Endosc 8: 721–722

3. Greene FL (1991) Training, credentialing and privileging for mini-mally invasive surgery. Prob General Surg 8: 502:506

4. Jakimowicz J (1994) The European Association for Endoscopic Sur-gery, recommendations for training in laparoscopic surgery. AnnChirurg Gynaecol 83: 137–141

5. Laparoscopic Surgery (June 12, 1992) New York State Department ofHealth Memorandum, Series 92-20, Albany, New York

6. Ooi, LLPJ Training in laparoscopic surgery–have we got it right yet?Ann Acad Med 25: 732–736

7. Wexner SD, Weiss EG (October 1994) A recommended trainingschema for laparoscopic surgery—the future of laparoscopy in oncol-ogy/surgical oncology clinics of North America, vol. 3, no. 4, 759–765

8. Wexner SD, Weiss EG (December 1994) Training and preparing forlaparoscopic colectomy. Semin Colon Rectal Surg 5: 224–227

9. SAGES (1991) Granting of privileges for laparoscopic general sur-gery. Am J Surg 161: 324–325

10. Schwaitzberg SD, Connolly RJ, Sant GR, Reindollar R, Clevland RJ(1996) Planning, development, and execution of and internationaltraining program in laparoscopic surgery. Surg Laparosc Endosc 6:10–15

11. See WA, Cooper CS, Fisher RJ (1993) Predictors of laparoscopiccomplications after formal training in laparoscopic surgery. JAMA270:

This statement was reviewed and approved by the Board of Governors ofthe Society of American Gastrointestinal Endoscopic Surgeons (SAGES)May, 1997. It was prepared by the SAGES Committee on Credentialing.

This is a revision of SAGES publication #0005 printed 5/90 and ofSAGES publication #0014 printed 1/92 and 10/92.

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Ultrasonic epithelial ablation of the lower esophagus withoutstricture formation

A new technique for Barrett’s ablation

R. M. Bremner, R. J. Mason, C. G. Bremner, T. R. DeMeester, P. Chandrasoma, J. H. Peters, J. A. Hagen,M. Gadenstatter

Department of Surgery, University of Southern California School of Medicine, 1510 San Pablo Street, Suite 514, Los Angeles, CA 90033-4612, USA

Received: 3 April 1997/Accepted: 6 October 1997

AbstractBackground: The premalignant potential of Barrett’sesophagus has stimulated efforts to find a way to ablate thecolumnar epithelium in order to reheal the area with squa-mous epithelium, thus obviating the cancer risk. This studydescribes and evaluates a new technique using ultrasonicenergy to ablate the epithelium of the lower esophagus in aporcine model.Methods:Eight young farm pigs were used to develop thetechnique of applying a laparoscopic Cavitron UltrasonicSurgical Aspirator (CUSA) to the lower esophageal mucosathrough an operating gastrostomy. A further 11 Yakutanminipigs then underwent CUSA epithelial ablation, fol-lowed by a laparoscopic Nissen fundoplication or postop-erative acid suppression therapy. We then assessed the heal-ing response in these subjects.Results:Optimal CUSA energy settings enabled completeablation of the squamous epithelium with preservation ofthe muscularis mucosa and submucosa. The integrity of theaspirated cells was sufficient for cytological analysis. Heal-ing occurred by squamous regeneration without strictureformation.Conclusions:The CUSA technique holds promise for com-plete ablation of the Barrett’s epithelium in a single setting.The unique tissue-selective nature of the ablative processallows complete mucosal reepithelialization without stric-ture formation.

Key words: Barrett’s esophagus—Epithelial ablation

The risk of developing adenocarcinoma in a segment of

columnar-lined Barrett’s esophagus is estimated at 0.8% peryear. This means that of 100,000 patients with Barrett’s, 800will develop adenocarcinoma. This risk is sufficient to en-courage annual endoscopic surveillance in patients withoutdysplasia. An alternative approach to surveillance is to ab-late the Barrett’s epithelium and encourage reepithelializa-tion of the ablated area with squamous epithelium. Ablationhas been performed with photodynamic therapy (PDT), la-ser therapy, and bipolar electrocoagulation [2–5, 7, 9]. Al-though all of these methods have had variable success, theyalso have demonstrated significant limitations that have hin-dered their wider application. This study evaluates a newtechnique that utilizes the tissue-selective nature of ultra-sonic energy to ablate the epithelium of the lower esophagusin a porcine model.

Methods

CUSA ultrasonic generator

The ultrasonic energy used in this experiment is generated by a CavitronUltrasonic Surgical Aspirator, or CUSA (CUSA Model 200, Valleylab Inc,Boulder, CO, USA). This generator is commonly used for liver resectionsand removal of brain tumors. The energy is delivered to the esophagealmucosa using an instrument that has been modified for laparoscopic access.The instrument is 30.1 cm long and consists of an energy tip measuring2.54 mm in diameter, coupled with an irrigation and suction channel (Fig.1). The tip vibrates at 23 kHz. The operator’s ability to adjust the amplitudevaries the energy transferred to the tissue. A patent ‘‘cavipulse’’ setting onthe instrument causes an oscillation of pulses at lower frequencies, whichenhances the selective tissue disruption and fragmentation.

Pilot and acute studies

An initial pilot study was performed in eight young farm pigs (60–80 lb)to ascertain the optimal CUSA settings for ablation of esophageal squa-mous epithelium and to determine the optimal port site placement to accessthe esophageal lumen by the CUSA probe. By trial and error, it was

Presented at the annual meeting of the Society of American Gastrointes-tinal Endoscopic Surgeons (SAGES), San Diego, California, USA, 19–22March 1997Correspondence to:T. R. DeMeester

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determined that placement of the port near the greater curvature of thestomach in the midline ensured easy access to the esophageal lumen andenabled the ultrasound tip to be applied to the full circumference of theluminal mucosa (Fig. 2). Optimal settings for epithelial ablation were de-termined by removing the esophagus from four animals, opening it longi-tudinally, and pinning the opened esophagus to a board. The CUSA wasapplied to the strips of esophageal mucosa using variable settings of am-plitude and cavipulse. The extent and depth of ablation was determined byhistologic examination. A cavipulse of 3 with 90–100% amplitude enabledablation of the epithelium while leaving the underlying muscularis mucosaand muscularis propria intact (Fig. 3). Higher cavipulse settings resulted insubmucosal hemorrhage and occasional disruption of the muscularis mu-cosa; lower amplitudes or cavipulse settings resulted in incomplete ablationof the epithelium. The chosen settings were then used to ablate the epi-thelium of the esophagus in the intact animals. After esophageal epithelialablation was attempted in four animals, the esophagus of each animal wasremoved and examined histopathologically to establish the completeness ofablation.

Operative studies

The mucosal ablation technique was used on 11 Yakutan minipigs, whowere allowed to recover. Five animals underwent CUSA ablation of thedistal 5 cm of the esophagus and were given Omeprazole 20 mg per day for7 days to prevent acid injury to the raw esophageal surface. Six animalsunderwent CUSA ablation followed by laparoscopic Nissen fundoplicationunder the same anesthetic. The Nissen fundoplication was performed byenveloping the lower esophagus, which was intubated with a 30-Fr bougiewith a tongue of gastric fundus, and then suturing it in place with twoEthibond sutures. It was not necessary to take down the short gastricvessels because the pig has a large, floppy fundus. The diaphragmatic crurawere sutured to close the dissection defect at the hiatus. The animals wereendoscoped at 2–4 weeks to assess healing of the mucosa. They were killedat 6 weeks using 6 cc of Euthasol (390 mg/ml pentobarbital) for euthanasia.The esophagus in each animal was resected and intubated with a Penrosedrain containing barium sulfate for radiographic examination to identifyany luminal narrowing or stricture formation. All specimens underwenthistological examination.

Operative technique

Prior to the procedure, the animals were fasted for 48 h to ensure an emptystomach, since Yakutan minipigs are known to have a prolonged gastricemptying time. Animals were anesthetized with 75 mg Telazol (tiletaminewith zelozepam 100 mg/ml), 35 mg xylozine, and 0.2 mg glycopyrolate.

Anesthesia was maintained with 0.5–2% isoflurane. The abdominal wallwas cleaned with betadine solution and draped in a standard sterile fashion.An Olympus endoscope was passed through the esophagus into the stom-ach and directed anteriorly. The room was darkened, and the light from thetip of the endoscope was visualized through the anterior abdominal wall. A16-gauge needle was passed percutaneously into the stomach using thelight source as a target. The entrance of the needle into the stomach wasmonitored visually through the endoscope. An operating gastrostomy tube(Cook Surgical, Cook Inc., Bloomington, IN, USA) was placed into thestomach using a standard percutaneous endoscopic gastrostomy technique(Fig. 2). The balloon of the port was insufflated with air to secure theanterior gastric wall to the anterior abdominal wall. Correct placement ofthe operating gastrostomy port was critical to enable the passage of a rigidlaparoscopic CUSA instrument through the gastroesophageal junction andinto the lumen of the lower esophagus. If the placement was incorrect, theCUSA instrument could not be applied to the complete circumference ofthe esophageal lumen.

An endoscope was placed in the upper esophagus to visualize theinsertion of the laparoscopic CUSA instrument into the esophagus. The tipof the CUSA probe was guided in a sweeping motion over the mucosallining, beginning cephalad and moving progressively caudad. The ablatedepithelial cells were collected from the central aspiration port and pre-served for cytology. The epithelium was ablated over a 5-cm circumfer-ential segment of lower esophagus just proximal to the gastroesophagealjunction. Epithelial ablation could be easily confirmed endoscopically byloss of the pearly-white appearance of the epithelium, thus revealing theunderlying dark red muscularis mucosa. There was no visible blood lossassociated with the ablation. Bleeding during the ablation usually indicatedan injury to the muscularis mucosa and disruption of submucosal capillar-ies. It could be avoided by using the correct CUSA power settings andavoiding repeated contact of the ultrasonic tip with previously ablatedareas. Care was taken to avoid excessive luminal insufflation, since ittended to cause distention of the small bowel. At the conclusion of theablation process, the operating gastrostomy port was removed and thegastrotomy closed with a running silk suture through a slightly enlargedskin incision at the gastrostomy site. The fascia was closed with interruptedProlene sutures, and the skin was closed with staples. The animals wererecovered and given buphrenex for postoperative pain management. Oralfeeding was started on the 1st postoperative day.

Ethics

This study was approved by the animal Use Committee of the Universityof Southern California (protocol number 8976).

Fig. 1. Photograph of the laparoscopic CUSA instrument.

Fig. 2. Diagram illustrating placement of the operating gastrostomy port.The laparoscopic CUSA is inserted through the port. An endoscope is usedto direct the CUSA into the lumen of the esophagus.

Fig. 3. Histologic view of the interface between the normal epithelium andthe area of ablation (×10 magnification). Note the absence of any epithelialcells in the ablated area. The muscularis mucosa is completely intact, andthere is no evidence of injury to the submucosa or muscularis propria. Themuscularis propia is not visible in the magnification; it is deep to the areashown.

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Results

Acute studies

Complete ablation of the epithelium of the lower esophaguswas possible through the operating gastrostomy port in allanimals. In all specimens, only the epithelium was ablated,leaving a thin coagulum overlying the muscularis mucosa.Macroscopically and histologically, no islands of epithe-lium were left in the area of ablation. The muscularis mu-cosa was intact in all animals, and no injury was observedeither in the submucosa or muscularis propria. The integrityof the aspirated cells was excellent and allowed for cyto-logical evaluation (Fig. 4).

Operative studies

Two of the 11 animals died during the 6-week observationperiod. One animal who underwent laparoscopic Nissenfundoplication died suddenly during the night on the 7thpostoperative day from a cecal volvulus with bowel infarc-tion. Pathology of the esophageal specimen revealed granu-lation tissue superficial to the muscularis mucosa; there wasno evidence of epithelial islands, confirming the effective-ness of the ablation technique. A second animal was notedat endoscopy 4 weeks after surgery to have herniated thefundoplication into the chest. The injury was due to failureto close the diaphragmatic crura at the time of fundoplica-tion. We found it prudent to kill the animal at this time eventhough she had been eating well and had not lost weight. Oninspection, the esophageal mucosa was completely reepi-thelialized and free from stricture.

The remaining animals were endoscoped at 2-week in-tervals. At 2 weeks, endoscopy showed areas of translucentwhite epithelium covering the granulation tissue in the ab-lated area. Histology of pinch biopsies showed epithelial-ization with three to six layers of squamous cells (Fig. 5). At4 weeks, epithelium covered the whole of the ablated areas,but it was slightly pink in color. By 6 weeks, completehealing had occurred without stricture formation, and theablated area could not be identified. Radiographic exami-

nation of the barium-filled Penrose drain passed through theintact specimen showed no evidence of stricturing (Figs. 6,7). On histological examination, all specimens were free offibrosis in the submucosa or the muscularis propria, and itwas difficult to distinguish normal from regenerated epithe-lium.

Discussion

Currently, there is no effective means of reversing the meta-plastic process associated with Barrett’s esophagus. Highdoses of proton pump inhibitors or antireflux surgery haveoccasionally resulted in total or partial regression of thecolumnar epithelium, but the occurrence is rare and unpre-dictable. Further, acid suppression therapy has not beenshown to prevent malignant progression of the columnarlining, and there is insufficient evidence at present that an-tireflux surgery is protective [8, 12]. Consequently, the In-ternational Society of Diseases of the Esophagus (ISDE)recommends that patients with Barrett’s metaplasia be en-doscoped and biopsied at yearly intervals in order to detectthe emergence of dysplasia, a sign of movement towardinvasive cancer [10]. The cost of surveillance over a lifetimeis significant. Added to this is the cost of esophagectomy ifhigh-grade dysplasia or cancer develops. Consequently, al-ternative approaches to the problem are being investigated.

Photodynamic therapy (PDT), laser ablation, and mul-tipolar electrocoagulation have all been used in humans toremove columnar epithelium with variable success [1–5, 7,9]. The results of published studies have shown that squa-mous reepithelialization of ablated areas occurs with squa-mous cells provided gastric acid secretion is suppressed.One limitation of these techniques is that the ablation ofBarrett’s epithelium is incomplete. There are reports ofsquamous overgrowth of partially ablated Barrett’s epithe-lium, as well as development of adenocarcinoma beneathsquamous reepithelialized areas [6]. Another drawback ofthese techniques is the inability to control the depth of tissueinjury, with resultant stricture formation inø50% of pa-tients.

The great advantage of ultrasonic energy is the tissue-

Fig. 4. The microscopic specimen of the cell block recovered from the aspiration port during the ablation (×100 magnification). The cells have maintainedtheir integrity for cytologic examination.

Fig. 5. Endoscopic pinch biopsy specimen obtained at 2 weeks after ablation showing the early regeneration of squamous epithelium with three to six celllayers (×40 magnification).

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selective nature of the ablative process. Tissue that has ahigh elastin or collagen content or that consists of musclecells is resistant to damage by the ultrasound energy. Thisexplains why the CUSA instrument can selectively ablatehepatic parenchymal cells while preserving the vascular andductal tissues during liver resections.

The aim of the present study was to develop a techniquewhereby ultrasonic energy could be used to ablate theesophageal epithelium without injury to the underlying tis-sue layers. The technique that we developed utilizes recentadvances in both endoscopy and laparoscopy. Selective ab-lation of the distal esophageal epithelium through the oper-ating gastrostomy port was easily accomplished once opti-mal CUSA settings were defined and the proper positioningof the gastrostomy site was determined. The impressivehistology of the acute experiments showed that completeablation of all squamous epithelium was possible withoutinjury to deeper layers of the esophageal wall. This explainswhy healing occurred in the absence of stricture formation.It is assumed that the columnar epithelium that occurs inBarrett’s metaplasia will act similarly, but this still needs tobe demonstrated.

A valuable feature of this technique is the ability tocollect the ablated epithelium by aspiration so that cytologicexamination can be performed. All techniques utilizingchemical or thermal means to destroy the epithelial cellsmake it impossible to detect occult carcinoma in the ablatedepithelium. In effect the aspiration specimen of the ultra-sonic ablative technique represents the ‘‘ultimate biopsy’’.

Although there was no objective difference in the heal-ing of the animals with a Nissen fundoplication, this is notto be interpreted that a Nissen fundoplication should not beperformed following ablation. The animals in this study hadnormal lower esophageal sphincters and therefore minimalesophageal exposure to gastric contents. This is not thesituation in patients with Barrett’s esophagus where thepresence of a defective sphincter is the rule (12). The struc-turally defective lower esophageal sphincter in patients withBarrett’s esophagus makes the medical management of re-flux tenuous at best. Even if the epithelium was successfullyablated in these patients, lifelong acid suppression therapywould still be required, and the potential for re-injury andmetaplasia would always remain. Consequently, without theaddition of a Nissen fundoplication, the need for strict sur-

Fig. 6. Necropsy specimens of resected esophagi after completemucosal healing.A Photograph of the esophagi intubated withbarium-filled Penrose drains of group 1 animals.B A radiograph ofthese esophagi demonstrates the absence of any luminal narrowing orstricture formation.C Four of the five esophagi from the animals thathad a Nissen fundoplication again demonstrating the absence of strictureformation. The fifth animal was killed at a different time but showedsimilar findings.

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veillance would continue. It is felt that the technique pre-sented in this study holds promise for the permanent eradi-cation of Barrett’s columnar epithelium and with it the riskof malignancy.

Acknowledgments.This work was supported in part by grants from SAGESand Valleylab Inc. (Boulder, CO, USA). We would like to acknowledgeHarry Valenta of Valleylab for his technical assistance and enthusiasmwith the project, and, Linda and Paul Kirkman of Animal Unit at USC fortheir care and help with the animals both intraoperatively and postopera-tively.

References

1. Barr H, Shepherd NA, Dix A, Roberts DJ, Tan WC, Krasner N (1996)Eradication of high-grade dysplasia in columnar-lined (Barrett’s)oesophagus by photodynamic therapy with endogenously generatedprotoporphyrin IX [see Comments]. Lancet 348: 584–585

2. Berenson MM, Johnson TD, Markowitz NR, Buchi KN, Samowitz WS(1993) Restoration of squamous mucosa after ablation of Barrett’sesophageal epithelium [see Comments]. Gastroenterology 104: 1686–1691

3. Brandt LJ, Blansky RL, Kauvar DR (1995) Repeat laser therapy ofrecurrent Barrett’s epithelium: success with anacidity [Letter]. Gastro-intest Endosc 41: 267

4. Overholt BF, Panjehpour M (1995) Barrett’s esophagus: photody-namic therapy for ablation of dysplasia, reduction of specialized mu-cosa, and treatment of superficial esophageal cancer [see Comments].Gastrointest Endosc 42: 64–70

5. Overholt BF, Panjehpour M (1996) Photodynamic therapy for Bar-rett’s esophagus: clinical update. Am J Gastroenterol 91: 1719–1723

6. Sampliner RE, Fass R (1993) Partial regression of Barrett’s esophagus:an inadequate endpoint. Am J Gastroenterol 88: 2092–2094

7. Sampliner RE, Fennerty B, Garewal HS (1996) Reversal of Barrett’sesophagus with acid suppression and multipolar electrocoagulation:preliminary results. Gastrointest Endosc 44: 532–535

8. Sampliner RE, Garewal HS, Fennerty MB, Aickin M (1990) Lack of

impact of therapy on extent of Barrett’s esophagus in 67 patients. DigDis Sci 35: 93–96

9. Sampliner RE, Hixson LJ, Fennerty MB, Garewal HS (1993) Regres-sion of Barrett’s esophagus by laser ablation in an anacid environment.Dig Dis Sci 38: 365–368

10. Skinner DB, Siewert JR (1996) Results of the consensus on esophagealcancer held at the VIth World Congress of the International Society forDiseases of the Esophagus 1995. Dis Esophagus 9: 1–56

11. Stein HJ, Hoeft S, DeMeester TR (1993) Functional foregut abnor-malities in Barrett’s esophagus. J Thorac Cardiovasc Surg 105: 107–111

12. Williamson WA, Ellis FH Jr, Gibb SP, Shahian DM, Aretz HT (1990)Effect of antireflux operation on Barrett’s mucosa [see Comments].Ann Thorac Surg 49: 537–541

Discussion

Dr. Hunter: Dr. Bremner, tell me a little bit about how youanticipate the utilization of this, and where you see yournext series of experiments going: Is this ready for humanapplication, and if so, what patients with Barrett’s are thosein whom you would consider utilizing this technique?

Dr. Bremner: To answer your first question first, Dr.Hunter, we anticipate using this now in Barrett’s tissue andcadaveric resected esophageal specimens to insure that ourassumption that this will work on Barrett’s epithelium is thesame as it works on squamous mucosa. It certainly, in theporcine stomach, seems to work very well; in fact, it seemsto ablate the columnar cells of the stomach even easier thanthe squamous cells. We anticipate that assumption to holdtrue. Then we anticipate taking it to human studies. Obvi-ously we would like to try patients with smaller segments ofBarrett’s initially. We anticipate that this would be a pro-cedure that would be performed at the time of laparoscopicNissen fundoplication, so under the same anesthetic ablat-ing the mucosa and then performing the Nissen. That wasone of the reasons for doing the Nissen fundoplication at thetime of ablation in the porcine model here. We had won-dered whether or not the raw surfaces of the epithelium,after ablation, won’t coapt after the addition of a Nissenfundoplication in the lower esophagus. It was our impres-sion, although we have no objective evidence, that the ani-mals that underwent Nissen fundoplication healed morequickly than those without the addition of an antirefluxprocedure, and possibly the reason for that is that pigs nor-mally have some physiologic reflux. We had acid suppres-sion in these animals only for a week; possibly some of thephysiologic reflux continued thereafter. We think it wouldneed to be done at the same time as an antireflux procedure.

Dr. Greene:I just had a question about the method of ap-proach. Realizing that the ultrasonic application has to bedone through a rigid system, would you anticipate that thiscould be done through a rigid endoscopic system from anoral approach, and would that benefit us, because we rec-ognize that all Barrett’s is not around the GE junction. Infact, we see Barrett’s changes well up into the esophagus. Iwonder what your thoughts would be—rather than trans-gastric, what would be the opportunity of an oral or even arigid approach?

Dr. Bremner:Thank you very much, Dr. Greene. It’s a goodquestion. We’ve been able to ablate the epithelium a whole13 cm up from the gastroesophageal junction, but that’s not

Fig. 7. An opened necropsy specimen of a healed esophagus 6 weeks aftermucosal ablation shows complete healing with no evidence of strictureformation.

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going to reach the entire esophagus in human Barrett’sesophagus. The limitation is the length of the instrument. Atthe moment it is 30.1 cm long, and so from the orogastricapproach you’re only going to get the upper esophagus. Butcertainly from above and below you’d be able to get theentire esophagus, if you needed to. Through a rigid esopha-goscope, I don’t anticipate that with the present technologywe’ll be able to reach the lower esophagus through themouth, but that’s just a technical limitation at the moment.

Dr. Mulvihill: I enjoyed this very much. I wondered if youhad any information on how rapidly there was restitution ofthis mucosa?

Dr. Bremner:We do, and it’s in the manuscript. We endo-scoped these animals during the healing process. One of the

animals had an early death from a cecal volvulus, and thatwas at postop day number 7. That enabled us to look at theesophageal specimen in its entirety at a week. This con-firmed that there was no epithelium left, and there was justa thin layer of granulation tissue over the muscularis mu-cosa. That is at one week. At two weeks we had someendoscopy specimens that showed that there are approxi-mately three to six layers of squamous epithelium; just athin layer of squamous epithelium already at two weeksover the entire surface. At four weeks it looked almosthealed, but endoscopically there was slack pink change be-tween the normal epithelium and the regenerated. At sixweeks we could hardly see any difference endoscopically,and our pathologist said it was very difficult for him to seeany difference between the normal squamous and the re-generated areas.

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