Acute Bleeding Varices

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Acute Bleeding Varices A Five-year Prospective Evaluation of Tamponade and Sclerotherapy JOHN TERBLANCHE, CH.M., F.R.C.S., F.C.S.(S.A.), HAMID 1. YAKOOB, M.B., F.C.S.(S.A.), PHILIP C. BORNMAN, M.MED, F.R.C.S., GREG V. STIEGMANN, M.D., ROY BANE, M.B., F.C.S.(S.A.), F.R.C.S., MIKE JONKER, M.B., F.C.S.(S.A.), F.R.C.S., JOHN WRIGHT M.B., M.R.C.P., RALPH KIRSCH, M.D., F.C.P.(S.A.) In a five-year study of massive upper gastrointestinal hemorrhage, 143 patients had esophageal varices diagnosed on emergency endoscopic examination. Seventy-one patients had active bleeding from varices and required Sengstaken tube tamponade during at least one hospital admission. The remaining patients included 33 with variceal bleeding which had stopped and 39 who were bleeding from another source. Sixty-six of the former group of 71 patients were referred for emergency injection sclerotherapy. These 66 patients were followed prospectively to August 1980, and had 137 episodes of endoscopically proven variceal bleeding requiring Seng- staken tube control followed by injection sclerotherapy during 93 separate hospital admissions. Definitive control of hemorrhage was achieved in 95% the patients admitted to the hospital (single injection 70%; two or three injections 22%). The death rate per hospital admission was 28%. No patient died of continued variceal bleeding, and exsanguinating variceal hemorrhage no longer poses a major problem at our hospital. The combined use of initial Sengstaken tube tampon- ade followed by injection sclerotherapy has simplified emer- gency treatment in the group of patients who continue to bleed actively from esophageal varices, despite initial con- servative treatment. pATIENTS WITH MASSIVE continued esophageal variceal bleeding constitute a major problem in clinical practice. Their management is difficult and time consuming and has an associated high mortality rate. These patients tend to drain the hospital's resources of blood. In a previous prospective study, Sengstaken tube tamponade was found to be highly effective in controlling bleeding temporarily, but definitive control Presented at the Annual Meeting of the American Surgical Association, Chicago, Illinois, April 22-24, 1981. Supported by grants from the South African Medical Research Council and the Staff Research Fund of the University of Cape Town. Reprint requests: Professor John Terblanche, Department of Surgery, University of Cape Town Medical School, Observatory, 7925, South Africa. From the Departments of Surgery and Medicine and the Medical Research Council Liver Research Group University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa of hemorrhage was only achieved in 40% of the patients after removal of the tube. Furthermore, despite various surgical maneuvers, 60% of the patients died during that hospital stay.I The present prospective study was designed to evaluate the combined use of Sengstaken tube tampon- ade for initial control of hemorrhage, followed by emergency injection sclerotherapy in patients with continued massive bleeding from esophageal varices. The major questions were whether this combined treatment would provide definitive control of hemor- rhage and improve survival of patients admitted to hospital with massive continued variceal bleeding. Assessment was, thus, limited to patients admitted to the hospital for variceal bleeding. A preliminary analysis at two years has been published.2 Materials and Methods All adult patients admitted to our hospital with suspected bleeding varices during a five-year period (August 15, 1975 to August 15, 1980) underwent emergency fiberoptic endoscopic examinations. Other patients with massive upper gastrointestinal bleeding had fiberoptic endoscopic examinations at 8.00 a.m. the morning after admission to the hospital. Three groups of patients with esophageal varices were identified. The first group of patients had active bleed- ing from esophageal varices at the time of endoscopic examination and required Sengstaken tube tamponade for control. Patients who fell into this category on their 0003-4932/81/1000/0521 $01.00 C) J. B. Lippincott Company 521

Transcript of Acute Bleeding Varices

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Acute Bleeding Varices

A Five-year Prospective Evaluation of Tamponade and Sclerotherapy

JOHN TERBLANCHE, CH.M., F.R.C.S., F.C.S.(S.A.), HAMID 1. YAKOOB, M.B., F.C.S.(S.A.),PHILIP C. BORNMAN, M.MED, F.R.C.S., GREG V. STIEGMANN, M.D., ROY BANE, M.B., F.C.S.(S.A.), F.R.C.S.,

MIKE JONKER, M.B., F.C.S.(S.A.), F.R.C.S., JOHN WRIGHT M.B., M.R.C.P.,RALPH KIRSCH, M.D., F.C.P.(S.A.)

In a five-year study of massive upper gastrointestinalhemorrhage, 143 patients had esophageal varices diagnosedon emergency endoscopic examination. Seventy-one patientshad active bleeding from varices and required Sengstakentube tamponade during at least one hospital admission. Theremaining patients included 33 with variceal bleeding whichhad stopped and 39 who were bleeding from another source.Sixty-six of the former group of 71 patients were referredfor emergency injection sclerotherapy. These 66 patients werefollowed prospectively to August 1980, and had 137 episodesof endoscopically proven variceal bleeding requiring Seng-staken tube control followed by injection sclerotherapyduring 93 separate hospital admissions. Definitive control ofhemorrhage was achieved in 95% the patients admitted to thehospital (single injection 70%; two or three injections 22%).The death rate per hospital admission was 28%. No patientdied of continued variceal bleeding, and exsanguinatingvariceal hemorrhage no longer poses a major problem at ourhospital. The combined use of initial Sengstaken tube tampon-ade followed by injection sclerotherapy has simplified emer-gency treatment in the group of patients who continue tobleed actively from esophageal varices, despite initial con-servative treatment.

pATIENTS WITH MASSIVE continued esophagealvariceal bleeding constitute a major problem in

clinical practice. Their management is difficult and timeconsuming and has an associated high mortality rate.These patients tend to drain the hospital's resourcesof blood. In a previous prospective study, Sengstakentube tamponade was found to be highly effective incontrolling bleeding temporarily, but definitive control

Presented at the Annual Meeting of the American SurgicalAssociation, Chicago, Illinois, April 22-24, 1981.

Supported by grants from the South African Medical ResearchCouncil and the Staff Research Fund of the University ofCape Town.

Reprint requests: Professor John Terblanche, Department ofSurgery, University of Cape Town Medical School, Observatory,7925, South Africa.

From the Departments of Surgery and Medicine and theMedical Research Council Liver Research Group

University of Cape Town and Groote SchuurHospital, Cape Town, South Africa

of hemorrhage was only achieved in 40% of the patientsafter removal of the tube. Furthermore, despite varioussurgical maneuvers, 60% of the patients died duringthat hospital stay.IThe present prospective study was designed to

evaluate the combined use of Sengstaken tube tampon-ade for initial control of hemorrhage, followed byemergency injection sclerotherapy in patients withcontinued massive bleeding from esophageal varices.The major questions were whether this combinedtreatment would provide definitive control of hemor-rhage and improve survival of patients admitted tohospital with massive continued variceal bleeding.Assessment was, thus, limited to patients admittedto the hospital for variceal bleeding. A preliminaryanalysis at two years has been published.2

Materials and Methods

All adult patients admitted to our hospital withsuspected bleeding varices during a five-year period(August 15, 1975 to August 15, 1980) underwentemergency fiberoptic endoscopic examinations. Otherpatients with massive upper gastrointestinal bleedinghad fiberoptic endoscopic examinations at 8.00 a.m.the morning after admission to the hospital. Threegroups of patients with esophageal varices wereidentified. The first group of patients had active bleed-ing from esophageal varices at the time of endoscopicexamination and required Sengstaken tube tamponadefor control. Patients who fell into this category on their

0003-4932/81/1000/0521 $01.00 C) J. B. Lippincott Company

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first or a later admission to the hospital during thetrial period were included in the present prospectivestudy. Detailed data were recorded on computer pro-forma sheets. The study protocol was passed by ourFaculty of Medicine's Ethical Review Committee.The second group of patients had esophageal

varices, but no other lesion. In these patients, adiagnosis of variceal bleeding that had stopped wasmade, and varices could only be presumed to be thecause of the bleed.Both the first and second groups were subsequently

considered for inclusion in a separate prospectiverandomized controlled clinical trial, comparing re-peated injection sclerotherapy with medical manage-ment in long-term treatment after variceal bleeding.The preliminary two-year data have been docu-mented3 and the five-year results will be published.The third group consisted of patients who, although

they had esophageal varices, were found to be bleedingactively from another lesion. Brief data on the lattertwo groups is included for comparison with the studygroup.

Management Protocol

The management protocol was outlined in the pre-liminary report2 and has been presented in detailelsewhere.4'5

Patients with massive upper gastrointestinal hemor-rhages were admitted to the medical service whereresuscitation was initiated. The protocol required thatbolus doses of pitressin be administered (20 units in100 ml 5% dextrose water given over 10 minutes andrepeated every 4 hours). As soon as the patient'scondition was stable, emergency endoscopic examina-tion was performed. Sengstaken tube tamponade wasreserved for those patients in whom active varicealbleeding was diagnosed at the time of endoscopicexamination. Emergency injection sclerotherapy wasrestricted to this group of patients. A period of 6-24hours was allowed prior to injection for resuscitationand to get the patient as fit as possible to undergoadministration of a general anesthetic. A coagulationprofile was obtained and defects corrected. Hepaticencephalopathy was treated with lactulose and/orneomycin, administered via the Sengstaken tube. At aconvenient time, usually within 24 hours of insertingthe Sengstaken tube, the patient was taken to theoperating room. A standard anesthetic technique wasused. Premedication consisted of atropine (0.6 mg) anddiazepam (5-10 mg), unless the patient was stuperoseor unconscious. The patient was administered anes-thetics of thiopentone sodium and suxamethonium.Anesthesia was maintained with nitrous oxide/oxygen

administered via an endotracheal tube, intermittentthiopentone and intermittent suxamethonium oralloferrin. The Sengstaken tube was removed after theendotracheal tube had been inserted and when thesurgeon was ready to insert the esophagoscope. The50 cm rigid Negus esophagoscope, modified with aslot at the distal end6 was inserted to the esophago-gastric junction. Bleeding rarely recurred at this time,but if it did it was immediately controlled once theesophagoscope reached the esophagogastric junction.Only one varix protruded into the slot, while theother variceal channels were compressed. Each chan-nel was injected with 6-8 ml of ethanolamine oleate.Intravascular injections were performed just abovethe esophagogastric junction. After injection of thefirst varix, immediate rotation of the esophagoscopecompressed that varix, trapped the sclerosant inposition, and prevented bleeding and loss of sclerosantfrom the needle puncture site. At the same time, asecond varix presented in the slot for injection.Usually three variceal channels required injection atthe first sitting. At the end of the procedure theesophagoscope was left in situ for an arbitrary fiveminutes, to provide further compression, and was thenremoved. After the first few patients had been treated,the Sengstaken tube was not replaced at the end of theprocedure, as this proved to be unnecessary and attimes was either difficult or dangerous. The patientswere returned to a surgical intensive care unit for 24-48hours. Feeding was commenced with oral fluids for 24hours. The patients were discharged from the hospitalas soon as they had recovered. If bleeding recurredin the hospital after injection, a repeat fiberopticendoscopic examination was performed to confirmvariceal bleeding. If active bleeding was present,Sengstaken tube tamponade and injection sclero-therapy were repeated. Recurrent bleeds after thepatient was discharged from hospital were managedin the same way.

Results

Emergency Endoscopic Examination

A total of 143 patients with massive upper gastro-intestinal hemorrhages had esophageal varices diag-nosed at endoscopic examination during the five-yearperiod ofthe study. Seventy-one patients were bleedingfrom varices at the time of endoscopic examinationand required Sengstaken tube tamponade. Thirty-threepatients had varices which had stopped bleeding,while 39 patients were bleeding from lesions other thantheir varices. None of these latter patients sub-sequently bled from esophageal varices, otherwisethey would have been included in the above groups.

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SCLEROTHERAPY FOR BLEEDING VARICES 523Variceal Bleeding Stopped Group

Twenty-one of the 33 patients in whom varicealbleeding had stopped were included in a separatechronic injection trial.3 Sixteen patients were ran-domized and the other five were injected out of trial.Detailed prospective data was available in all 21patients. They were admitted to the hospital 27 timesfor separate variceal bleeds during the trial period.There were 15 males and six females in this group.The average age was 51 years (range: 29-80 years).The initial modified Child's risk grades3 were A-8;B-9; C-9; not estimated-1. Alcoholic cirrhosis wasdiagnosed in 11 patients (52%), cryptogenic cirrhosisin 6 and "other" in four (including one patient withhemochromatosis and three unknown). Seven patientsdied (liver failure or multiple organ failure in six andsubarachnoid hemorrhage in one) giving an admissionmortality rate of 26%. The remaining patients provedeasy to manage. The average blood requirement peradmission was 4.5 units. No patient required Seng-staken tube tamponade during any admission.Twelve of the 33 patients were either not referred

to the authors or did not meet the criteria for inclusionin the chronic trial.3 Four of these patients died (42%mortality rate).

Bleeding from Another Lesion Group

The 39 patients with varices who were bleeding fromother lesions, were admitted to the hospital total of 43times during the study period. The source of bleedingis shown in Table 1. The bleeding lesions were managedin the usual way. There were ten deaths during the43 admissions (admission mortality rate: 23%). Alldeaths occurred in patients with gastritis and erosionsor with peptic ulceration.

TABLE 1. Bleeding Source Other than Varices:39 Patients 43 Admissions

Hospital Admissions

Per- MortalityLesion Number centage Ratet

Gastric ulcer 9 21 3/9 33%Duodenal ulcer 7t 16 2/7 29oGastritis and erosions 17* 40 5/17 29oEsophagitis 3 7 0Mallory Weiss Tear 4t 9 0Hered. telangectasia 1 2 0Unknown 2 5 0

* One patient admitted four times with this diagnosis.t One patient admitted with duodenal ulcer and Mallory Weiss

tear on two separate admissions.t Overall admission mortality 23%.

TABLE 2. Cause of Portal Hypertension: 66 Patients in Study

Number ofDiagnosis Patients Percentage

Alcoholic cirrhosis* 36 55Cryptogenic cirrhosist 16 24Cirrhosis (+ carcinoma) 3 4Portal vein thrombosis 6 9Other: 5 8

* Includes 6 established alcoholic patients diagnosed on clinicalcriteria without biopsy.

t Includes 5 with histological evidence of chronic active hepatitis.t 2 congenital hepatic fibrosis; 2 undiagnosed; 1 normal histology.

Study Group: Continued Variceal Hemorrhage

Patient data. Sixty-six of the 71 patients whopresented during one or more admissions with con-tinued variceal bleeding requiring Sengstaken tubetamponade were referred for injection sclerotherapy.Five patients were not referred and have been ex-cluded from the analysis. These five patients diedduring the first hospital admission, four from con-tinued or subsequent upper gastrointestinal bleeding.This group represents a communication failure in alarge institution.The 66 patients included in the study had 137 separate

variceal bleeds requiring initial Sengstaken tamponadeduring 93 admissions to hospital, and underwent 127emergency injections. There were 51 males and 15 fe-males in this group of patients. The average age of thepatients on first admission to the hospital was 47 years(range: 13-80 years). The initial modified Child's riskgrade3 was A- 14; B- 30; C- 19; not estimated- 3. Thecause of the portal hypertension is shown in Table 2.

Control ofhemorrhage. Sengstaken tube tamponadecontrolled hemorrhage, initially, in all 137 bleeds.Using the combination of the Sengstaken tube andsubsequent injection sclerotherapy, ultimate control ofhemorrhage was achieved in 88 of the 93 patients ad-mitted to the hospital (95%). Five patients have beenclassified as failures. Two moribund patients dying ofliver failure, and in whom active treatment had beendiscontinued, had bleeding as a terminal event (onefive days after two injections, and the other three daysafter four injections had initially controlled bleedingtemporarily). Although bleeding was controlled in theother three patients, they are considered as failuresof injection sclerotherapy, as they required an Hassabdevascularisation procedure7 before hemorrhage wascontrolled. Two patients included in the previousreport as esophageal tears with the rigid esophago-scope,2 but who have been reclassified as injectionsite leaks, had the devascularisation procedure per-formed, as it was felt that further injections with a

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TERBLANCHE AND OTHERS524TABLE 3. Injections Required to Control

Hemorrhage in 88 Admissions

AdmissionsAverage Units

Injections: Per- Blood perNumber Number centage Admission

One 62 70 62-3 19 22 174 1 1 17>4 0None 6 7 5

rigid endoscope were contraindicated. Both patientshad a successful devascularization. Neither patientrebled during that hospital stay, but only one survived.The third patient was a true failure of injection sclero-therapy as four injections failed to control bleedingduring a single admission. Although control of hemor-rhage was achieved after the devascularization opera-tion, he died a week later of liver failure. Autopsyexamination demonstrated cirrhosis and hepatocellularcarcinoma. Despite the 5% failure rate, bleeds wereusually fairly easily controlled, and exanguinatingvariceal hemorrhage no longer poses a majorproblem.Number of injections required for control. The

number of injections required in the 88 admissionswhere control of variceal hemorrhage was achievedis shown in Table 3. The majority of patients (70%)had the bleeding controlled with a single injection, 22%required two or three injections, one patient requiredfour injections. No patient had more than four in-jections. In a further six admissions, injection was notperformed. In two patients the esophagoscope couldnot be passed for technical reasons (esophageal weband esophageal stenosis following a previous injectionrespectively). Both patients had cessation of bleeding.In two patients, protocol failure resulted in the Seng-staken tube being removed without injection. Neitherpatient rebled. Finally, two severely ill patients diedof liver failure with hemorrhage controlled by theSengstaken tube before injections could be adminis-tered. In four additional admissions, a repeat bleedafter initial control was treated with the Sengstakentube, but subsequent injection was prevented fortechnical reasons (mucosal slough in two, edema andstenosis in one each). Bleeding was controlled in allfour patients. Patients requiring more than one in-jection tended to have larger bleeds which were more

difficult to control. The average number of units ofblood required per admission in the various groups

is shown in Table 3.Fiberoptic endoscopy for recurrent bleeds. Our

protocol required repeat emergency fiberoptic- endo-

scopic examination if a patient rebled after injectionsclerotherapy during a hospital stay. On only one oc-casion was a lesion other than the varices diagnosedas the cause of the rebleed. This was a gastric ulcerwhich had probably been missed at the first endo-scopic examination. Seven additional patients in thestudy group had a cause of bleeding other than theirvarices diagnosed in a subsequent admission after aninitial bleed requiring Sengstaken tube tamponadeand injection sclerotherapy (five patients with gastritisand erosions; one with a gastric ulcer; one with aduodenal ulcer).

Mortality rate. For the purpose of this study, deathwas defined as death during a hospital stay for varicealbleeding during the trial period. There were 26 deathsduring 93 hospitalization periods, for a 28% mortalityrate per hospital stay. The mortality rate per varicealbleed was l9o (26 deaths in 137 variceal bleeds). Thecauses of death are shown in Table 4.

Liver failure was the predominant cause of death(21 patients) and was usually associated with pre-terminal multiple organ failure (14 patients). Liverfailure was also the main cause of death in the twomoribund patients, in whom treatment was discon-tinued and who had a terminal variceal bleed. In thisgroup of patients the modified Child's risk grade wasC when measured before death. The three deaths dueto complications of treatment all occurred in the earlypart of the study, and were documented in the pre-liminary publication.2 One patient bled from a gastricerosion after the Sengstaken tube had been left in situtoo long, and another was a result of esophagealperforation caused by inflation of the gastric balloonwith water instead of air after it had curled back in theesophagus while being reinserted after injection. Bothpatients had associated severe liver failure. The patientwith the esophagoscopy and injection complication waspreviously classified as having an esophageal tear,2 buthas been reclassified as an injection site leak. Thispatient developed a subphrenic abscess related to a

TABLE 4. Causes of Death: 26 Patients During 93 Admissions

Cause of Death Number

Liver failure 21primarily liver failure 5associated multiple organ failure 14associated terminal variceal bleed 2

Complications of treatment 3Sengstaken tube 2esophagoscopy and injection I

Cardiorespiratory 2fulminant pneumonia 1cardiorespiratory arrest I

Uncontrolled variceal bleeding 0

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TABLE 5. Major Complications*

Complication Number

Sengstaken tube 2gastric erosion 1esophageal perforation 1

Esophagoscopy and injection 13esophageal perforation 0injection site leak 6esophageal stenosis 2mucosal slough:

severe 3mild 2

Severe pneumonia 7

* There were 22 complications in 18 patients during 93 admissions.

feeding gastrostomy, and died of liver failure andsepsis. One of the patients who had cardiorespiratoryfailure died primarily of fulminant pneumonia, but hadassociated liver failure. The other patient had a cardio-respiratory arrest without severe liver dysfunction. Nopatient died primarily of continued or uncontrolledvariceal hemorrhage.Major complications. Twenty-two complications oc-

curred in 18 patients during the 93 admissions (Table5). The two major Sengstaken tube complications wereresponsible for the patients' deaths. They occurred

during the first six months of the trial and should beavoidable. The two patients classified as esophagealtears caused by the rigid esophagoscope in the pre-vious publication2 have been carefully re-evaluatedand reclassified as injection site leaks. One patientdied a month later with a subphrenic abscess relatedto a feeding gastrostomy and the other settled com-pletely on hyperalimentation. Injection site leaks havenot proved to be a serious complication in our laterexperience. They have occurred in four additionalpatients, and resolved spontaneously with eitherintravenous hyperalimentation or nasogastric feedingvia a fine Silastic tube, plus antibiotics. The clinicalcourse in one patient is depicted in Figure 1. Five ofthe six patients survived. The incidence rate per in-jection was 5% (six in 127 injections). Two patientsdeveloped esophageal stenosis after an injection for anacute bleed. Both occurred early in the series and wereincluded in the preliminary report.2 Three patientsdeveloped significant mucosal slough, which preventedfurther injections in two, although bleeding stoppedspontaneously. Two patients survived and have noresidual problems, but the other died of multiple organfailure. One of the former was associated with an in-jection site leak. Two further patients had a mild

:.. j .:i~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~....

Fig. 1. Injection Site Leak (A) This demonstrates a significant injection site leak (2-25-80). (B) By one week there was a marked improve-ment. (C) The esophagus had returned to normal by 3-21-80, although varices were still present. Systemic antibiotics were administeredand the patient kept nil by mouth and fed via a small Silastic nasogastric tube.

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mucosal slough which did not interfere with manage-ment. Severe pneumonia is a universal problem inpatients with massive gastrointestinal bleeding fromesophageal varices. It occurred seven times duringthe 93 admissions. The incidence per major bleed was5% (seven in 137 bleeds). In only one patient was it themain cause of death. In three other patients it con-tributed to their death, although the major cause wasliver and multiple organ failure.

Discussion

The results of this five-year prospective study of thecombined use of initial Sengstaken tube tamponadefollowed by emergency peresophageal injection sclero-therapy lend support to the conclusion of the pre-liminary two-year analysis that this combined tech-nique is the emergency treatment of choice for thegroup of patients who continue to bleed from endo-scopically proven esophageal varices, despite initialconservative management.2 Randomized controlswithout injection were not included, because it was

felt to be ethically unjustified to withhold injectionsclerotherapy in patients who required Sengstakentube tamponade. In the previous Cape Town ex-perience, the rebleed rate after removal of theSengstaken tube had been 60% and the hospital ad-mission mortality rate was 60%.1Although emergency endoscopic examination is

mandatory to ensure that the patient is actually bleed-ing from varices,'2 there are problems. A confidentdiagnosis can only be made if a bleeding varix is seen,or if another lesion is seen to be bleeding. With amassive upper gastrointestinal hemorrhage, visionis often obscured, and the diagnosis of bleeding varicesis less secure. In our previous experience, one-thirdof the patients with endoscopically proven variceswere bleeding from another source.1 In the presentseries, with the inclusion of the eight patients whobled from another lesion after entry into the study andthe additional cases that bled from other lesions prior toentry, the figure remains at about one-third. It is stillessential to perform emergency fiberoptic endoscopicexamination in patients who are readmitted to thehospital with suspected variceal bleeds after a provenprevious variceal bleed, as seven of the 66 patientswere bleeding from another lesion on one of the 27subsequent admissions (26%). However, our data sug-gest that repeat emergency endoscopic examination isnot necessary for recurrent bleeds after injectionsclerotherapy in a single admission, since bleedingwas from varices in all but one patient, in whom a

gastric ulcer had probably been missed at the firstendoscopic examination. These repeat bleeds should

be treated by immediate reinsertion of the Seng-staken tube and reinjection.

Patients with variceal bleeding which stops duringinitial conservative management, prior to endo-scopic examination, are usually easy to manage andrequire no further emergency treatment for theirvarices unless they bleed again. Studies that do notidentify and separate these good risk patients in ana-

lyzing results, should be critically evaluated. Althoughno patient in this category died during the first twoyears,2 there was a 26% overall mortality rate atfive years. Most deaths were due to liver failure andblood loss contributed minimally, if at all. This em-phasizes that, even if bleeding is controlled, the under-lying liver disease remains an important determinantof prognosis. The same applies to patients bleedingfrom sources other than their varices, although thepresent mortality rate of 23% is better than in some

reported series.8The initial management is also important in deter-

mining survival rates. In the Cape Town patients, thiswas undertaken by the resident staff on the generalmedical services. Changing staff in a large institutionhas led to some protocol failures. The use of bolusdoses of pitressin, as dictated by the trial protocol, wasa deficiency in the present study, as current evidencefavors continuous intravenous infusion of pitres-sion.A2 Although encouraging, the remarkable suc-cess rate achieved with intravenous pitression in asmall sequential study in Liverpool'" has not beenconfirmed by the New Haven series, where the controlrate was only 50%. 12 Nevertheless, since the trialclosed, we have changed to intravenous infusion ofpitressin (0.4 units per minute). A correctly situatedSengstaken tube proved highly effective and con-trolled bleeding temporarily in all patients, despite con-trary views in the literature.'3 Attention to detail isimportant" '4 and the tube should only be used if initialconservative management fails. No serious complica-tions were encountered after the first six months of thestudy. The detailed Cape Town technique is presentedelsewhere.45 Continued bleeding indicates an incor-rectly situated tube, or that bleeding is from anothersource. If bleeding continues after expert reposi-tioning of the Sengstaken tube, repeat emergencyendoscopic examination will usually reveal the othersite of bleeding. Important advantages of initial Sengs-taken tube control are that patients are no longer ac-tively bleeding when injected 6-24 hours later, whichgreatly reduces the hazards of the technique, that theycan be rendered as fit as possible prior to a generalanesthetic, and that the emergency injection pro-cedure can be performed at a convenient timeduring daylight hours.

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SCLEROTHERAPY FOR BLEEDING VARICES 527By combining Sengstaken tube tamponade with

injection sclerotherapy in the difficult group of pa-tients, with continued variceal bleeding, ultimate con-trol of hemorrhage was achieved in 95% of the patientsadmitted to the hospital usually with a single injection(70%). If the two moribund patients, in whom treat-ment had been discontinued, and who died of liverfailure with a terminal variceal bleed, are excluded, thecontrol of hemorrhage is 97%. This compares favor-ably with previous reports using injection sclero-therapy. '15"16 On the other hand, in our previous pro-spective study using the Sengstaken tube alone, ulti-mate control of hemorrhage was only achieved in 40%of the patients.' Thus, although the Sengstaken tubecontrols hemorrhage temporarily, an additional pro-cedure is required to obtain definitive control. It isimportant to recognize that injection sclerotherapy canoccasionally fail to control variceal bleeding. In theserare patients, we would currently recommend that analternative surgical procedure be performed withoutdelay when early rebleeding occurs after two or threeinjections. To date, we have used the Hassab de-vascularisation procedure,7 but only as a last resort.Although it has always controlled bleeding, only one ofthe three patients ultimately survived.The 28% admission mortality rate in the completed

five-year study was disappointingly no better than the25% mortality rate noticed at two years,2 despiteelimination of deaths due to complications of treat-ment (Sengstaken tube and esophagoscopy and injec-tion). It probably reflects increased referral of poorrisk patients from other institutions. No patient died ofcontinued uncontrolled variceal bleeding, which hadbeen a problem in our previous experience. Otherworkers have achieved similar results using this andalternative techniques for injection sclerotherapy.'6-'9Among the advantages of injection sclerotherapy areits simplicity and the fact that major abdominal orthoracic operations are avoided in poor risk patients.The present results represent a marked improvementin survival rate, when compared with our previousprospective study of the Sengstaken tube withoutinjection in similar patients, where 60% rebled on re-moval of the tube and many were ultimately under-went emergency surgery. In this group of patients, theadmission mortality rate was 60%.'

This series included the authors' total experience ofinjection sclerotherapy, and complications should beassessed in this light. Twelve of 22 patients (55%) hadone or more complications by two years,2 but by fiveyears this was only 18 out ofa total of66 patients (27%).The Sengstaken tube was safe, and complications couldbe avoided if properly used." 4'5"14 The balloons shouldbe filled with air and not water or oily contrast media,

which can be difficult to insert and to remove. Thepathogenesis of what we have termed "injection siteleaks" remains unclear. It is possibly due to localizedslough of the deeper tissues with an incorrectly deeplyplaced injection. Although it looked frightening oncontrast swallows, it remained localized in all cases,and resolved rapidly with conservative management.It must not be misinterpreted as an esophageal tear,as occurred in the first two cases, otherwise unneces-sary major surgery may be performed. Other thanpneumonia and the occasional severe mucosal slough,the procedure has remained remarkably complication-free, particularly with increased experience.A wide-bore rigid esophagoscope has been used

under general anesthesia and the technique has beencriticized on both scores. However, it has proved suc-cessful. The modified Negus esophagoscope has anumber of advantages, which have been stated pre-viously.20 Its proximal light source does not becomeobscured if bleeding occurs. Only one distended varixprojects into the slot, thereby facilitating injection,while the other variceal channels are compressed by thewide-bore scope. As the needle is withdrawn from thefirst varix, immediate rotation of the esophagoscopecompresses this varix, which promotes sclerosis andprevents bleeding or loss of sclerosant from the needlepuncture site. At the same time, a second varix presentsin the slot ready for injection. Thereafter, the third oradditional channels can be injected while compressingthe already injected varices. Standard fiberopticesophagoscopes do not offer any of these advantages.The disadvantages include the need for technical skillto perform rigid endoscopic examination. In CapeTown, the injections have been performed by two ofthe senior authors and a succession of senior residentsinvolved in the study, who have rapidly learned thetechnique. Technical details are fully described else-where.4'5 Fiberoptic endoscopic injection slerotherapyis being increasingly reported, but some techniquesstill require a general anesthetic, which removes amajor advantage of using a fiberoptic scope. These in-clude the Kings College Hospital group who havedeveloped a sheath to use with the fiberoptic scope.'9'21The use of balloons, which are either attached to thescope22 or distal to the scope,'7 to achieve compres-sion are exciting possibilities which require furtherevaluation. Others have injected sclerosant directlyinto the varices without balloon compression.23 In thepresent study, the injection had been placed intravas-cularly into the varix to induce thrombosis. An alter-native technique is submucosal injection adjacent tothe varix with the aim of thickening the mucosa and,thereby, preventing rebleeding. This has been widelypracticed in Europe'8'24 with excellent results. The

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528 TERBLANCHE AND OTHERS Ann. Surg.*October 1981

largest series is that of Paquet.'8 The authors are cur-rently evaluating this technique using a fiberopticscope without anesthesia with a view to a controlledtrial comparing it with their intravascular techniquewith the rigid endoscope. The sclerosant ethanolamineoleate used by the authors, and in the large Belfastexperience,16 has not been available in the UnitedStates. Sodium morrhuate 5%, which was used by someof the pioneers, has been successful recently17'25 andappears to be a satisfactory alternative. Possibly only4-6 ml should be injected into each varix. Althoughthe authors have avoided highly irritant solutions suchas sotredechol (STD), because of the fear ofesophagealslough if injected extravascularly, the group in Bris-bane have used it successfully via the fiberopticscope.23The case for using injection sclerotherapy rather

than other techniques has been detailed else-where.4'26 The authors do not believe that emergencyportosystemic shunting operations27'28 are justifiedwhen a simple technique will suffice. Devasculariza-tion and transsection procedures had an associatedhigh mortality rate in the past, and should probablybe reserved for the rare failures of injection sclero-therapy. Despite the good results reported from Japan,the massive devascularization and transsection pro-cedure of Sugiura29 also seems unjustified. Esophagealtranssection with the stapling gun has been proposedas a viable alternative30'31 but even here there have beenproblems in the setting of acute bleeds.32 Finally,percutaneous transhepatic obliteration of varices hasbeen an attractive alternative, particularly in the lightof the excellent results achieved by Viamonte, inMiami.33 However, the group in Lund, Sweden, whooriginated the technique,34 have emphasized its prob-lems and no longer advocate this procedure for acutebleeding. The major problems have been portal veinthrombosis (36%), a high rebleed rate (55%) and dif-ficulty in repeating the procedure in long-term treat-ment.35 Portal vein thrombosis has also been re-ported by others.36'37

Patients with suspected esophageal variceal bleedingrequire emergency endoscopic examination to provethat varices are the source of bleeding. Major ordangerous procedures should not be performed unlessbleeding continues after trying simple measures. Wherebleeding continues despite pitressin therapy, a cor-rectly situated Sengstaken tube will stop bleedingtemporarily. Subsequent emergency peresophagealinjection sclerotherapy will ensure definitive controlof bleeding in 95% of the patients. Although theauthors favor rigid endoscopic examination undergeneral anesthesia, various fiberoptic techniques with-out general anesthesia require further evaluation

in controlled trials comparing them with the establishedrigid endoscopic techniques.

AcknowledgmentThe Medical Superintendent of Groote Schuur Hospital is thanked

for permission to publish the patient data.

References1. Novis BH, Duys P, Barbezat GO, et al. Fibreoptic endoscopy

and the use of the Sengstaken tube in acute gastrointestinalhaemorrhage in patients with portal hypertension andvarices. Gut 1976; 17:258-262.

2. Terblanche J, Northover JMA, Bornman P, et al. A prospectiveevaluation of injection sclerotherapy in the treatment ofacute bleeding from esophageal varices. Surgery 1979;85:239-245.

3. Terblanche J, Northover JMA, Bornman P, et al. A prospectivecontrolled trial of sclerotherapy in the long term manage-ment of patient after esophageal variceal bleeding. SurgGynecol Obstet 1979; 148:323-333.

4. Terblanche J. Treatment df esophageal varices by injectionsclerotherapy. In Jordan GL, Hardy JD, Longmire WP, et al.(ed) Advances in Surgery. Chicago, Year Book MedicalPublishers, 1981. (in press).

5. Terblanche J. Injection sclerotherapy for esophageal varicealbleeding. In Myhus LM, Cole WH, Baker RJ, (eds) Masteryof Surgery. Chicago, Little Brown & Co, 1981. (in press).

6. Bailey ME, Dawson JL. Modified esophagoscope for injectingesophageal varices. Br Med J 1975; 2:540-541.

7. Hassab MA. Nonshunt operations in portal hypertensionwithout cirrhosis. Surg Gynecol Obstet 1970; 131:648-654.

8. Wirthlin LS, Van Urk H, Malt RB, Malt RA. Predictors ofsurgical mortality in patients with cirrhosis and nonvaricealgastroduodenal bleeding. Surg Gynecol Obstet 1974; 139:65-68.

9. Barr JW, Larkin RC, Rosch J. Similarity of arterial andintravenous vasopressin on portal and systemic hemo-dynamics. Gastroenterology 1975; 69:13-19.

10. Sagar S, Harrison ID, Brearley R, Shields R. Emergencytreatment of variceal haemorrhage. Br J Surg 1979; 66:824-826.

11. Johnson WC, Widrich WC, Ansell JE, et al. Control of bleed-ing varices by vasopressin: a prospective randomizedstudy. Ann Surg 1977; 186:369-376.

12. Chojkier M, Groszmann RJ, Atterbury CE, et al. A con-trolled comparison ofcontinuous intraarterial and intravenousinfusions of vasopressin in hemorrhage from esophagealvarices. Gastroenterology 1979; 77:540-546.

13. Chojkier M, Conn HO. Esophageal tamponade in the treatmentof bleeding varices. A decadal progress report. Dig Dis Sci1980; 25:267-272.

14. Pitcher JL. Safety and effectiveness of the modified Seng-staken-Blakemore tube: a prospective study. Gastro-enterology 1971; 61:291-298.

15. Macbeth R. Treatment of esophageal varices in portal hyper-tension by means of sclerosing injections. Br Med J 1955;2:877-880.

16. Johnston GW, Rodgers HW. A review of 15 years' experiencein the use of sclerotherapy in the control of acute hemor-rhage from esophageal varices. Br J Surg 1973; 60:797-800.

17. Lewis J, Chung RS, Allison J. Sclerotherapy of esophagealvarices. Arch Surg 1980; 115:476-480.

18. Paquet K-J, Oberhammer E. Sclerotherapy of bleedingesophageal varices by means of endoscopy. Endoscopy 1978;10:7-12.

19. Clark AW, Macdougall BRD, Westaby D, et al. Prospectivecontrolled trial of injection sclerotherapy in patients withcirrhosis and recent variceal haemorrhage. Lancet 1980; 2:552-554.

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20. Terblanche J. Treatment of esophageal varices (Editorial). J SocMed 1979; 72:163-166.

21. Williams KGD, Dawson JL. Fibreoptic injection of esophagealvarices. Br Med J 1979; 2:766-767.

22. Brooks WS. Adapting flexible endoscopes for sclerosis ofesophageal varices. Lancet 1980; 1:266.

23. Harris OD, Dickey JD, Stephenson PM. Simple endoscopicinjection sclerotherapy of oesophageal varices. 1981; (sub-mitted for publication).

24. Wodak E. Akute gastrointestinale blutung; resultate derendoskopischen sklerosierung von osophagusvarizen.Schweiz Med Wschr 1979; 109:591-594.

25. Lilly JR. Endosclerosis of esophageal varices in children.Surg Gynecol Obstet 1981; (in press).

26. Terblanche J. Bleeding esophageal varices secondary tohepatic cirrhosis: Treatment by peresophageal injectionsclerotherapy. In Varco RL, Delaney JP, (eds) MoreControversies in Surgery. Philadelphia, WB Saunders Co.1981. (in press).

27. Orloff MJ, Bell RH, Hyde PV, Skivolocki WP. Long-termresults ofemergency portacaval shunt for bleeding esophagealvarices in unselected patients with alcoholic cirrhosis. AnnSurg 1980; 192:325-340.

28. Malt RA, Abbott WM, Warshaw AL, et al. Randomized trialof emergency mesocaval and portacaval shunts for bleedingesophageal varices. Am J Surg 1978; 135:584-588.

29. Sugiura M, Futagawa S. Further evaluation of the Sugiuraprocedure in the treatment of esohageal varices. Arch Surg1977; 112:1317-1321.

30. Johnston GW. Simplified oesophageal transection for bleedingvarices. Br Med J 1978; 1:1388-1391.

31. Takasaki T, Kobayshi S, Muto H, et al. Transabdominalesophageal transection by using a suture device in cases ofesophageal varices. Intern Surg 1977; 62:426-428.

32. Johnston GW. Bleeding esophageal varices: The managementof shunt rejects. Ann R Coll Surg Eng 1981; 63:3-8.

33. Viamonte M, Pereiras R, Russell E, et al. Transhepatic oblitera-tion of gastroesophageal varices. Results in acute and non-acute bleeders. Am J Roentgenol 1977; 129:237-241.

34. Lunderquist A, Vang J. Transhepatic catheterization and ob-literation of the coronary vein in patients with portal hyper-tension and esophageal varices. N Engl J Med 1974; 291:646-649.

35. Bengmark S, Borjesson B, Hoevels J, et al. Obliteration ofesophageal varices by PTP. A follow-up of 43 patients. AnnSurg 1979; 190:549-554.

36. Henderson JM, Buist TAS, MacPherson AIS. Percutaneoustranshepatic occlusion for bleeding oesophageal varices. Br JSurg 1979; 66:569-571.

37. Passariello R, Thau A, Lombardi M, et al. Control of gastro-esophageal bleeding varices by percutaneous transhepaticportography. Surg Gynecol Obstet 1980; 150:155-160.

DISCUSSION

DR. EDWARD E. MASON (Iowa City, Iowa): At the University ofIowa, Dr. Jeffrey Lewis has been using injection sclerotherapy fortwo years. He would like for me to make five points.

Sclerotherapy is used to control hemorrhage acutely. He uses afiberoptic endoscope, which obviates the need for general anesthesia.The procedure is performed as soon as the diagnosis is made, gen-erally in the emergency room at the time of admission to the hospital.He never uses the Sengstaken-Blakemore balloon or vasopressin,thus avoiding the serious risks of these two modes. Dr. Lewis usessodium morrhuate, which he injects into the lumen of the varix. Youcan see the varix turn white. The blood, which is spurting acrossthe lumen, quits spurting. When the needle is removed, there is alittle bit of ooze for a few minutes, and then it quits. The patient iskept in an upright position, so that the blood pools in the stomach,which makes it possible to do this. When he completes the injectionof all visible varices, he then uses the endoscope and high suctionto such out the clots and blood, so that the patient will not aspirate.The results in 39 of the 90 patients he has treated who had acute

bleeding were control of hemorrhage obtained in 96%, and 30-daysurvival in 76%; this is with no selection. One of the beauties ofthe technique is that you can treat poor-risk patients, as well asgood-risk patients. No portosystemic shunts have been performedin two years in our hospital, and that is not because some of usdid not have quite an interest in it.

Dr. Lewis is now involved in a controlled prospective study, andI must say that he has great control to perform endoscopy on apatient in the operating room, see blood spurting across the lumen,and draw a card, then turn the patient over to the internist fortreatment with a Sengstaken-Blakemore tube, and sometimes lateron to take care of the patient when the patient is really in poor shape.

DR. Louis R. M. DEL GUERCIO (Valhalla, New York): For thelast few years, we have been interested in splenic artery ligationas treatment of selected instances of portal hypertension. Althoughmost of the patients have portal pressures reduced below the 30 cmH2O level, some of them are left with residual varices, which we arenow treating by sclerotherapy.

In instances of acute hemorrhage in which celiac angiography

reveals a large splenic artery and rapid splenic transit, transcathetericocclusion of the artery may reduce pressure considerably.We now prefer to use Gianturco coils percutaneously to occlude

the splenic artery, since the coils are now available as large as 15 mm.Then, using the Vang-Lunderquist transhepatic portographic tech-nique, we put Gianturco coils in the coronary vein and in any residualshort gastric veins.

After this procedure there are no longer large amounts of arterio-venous shunts in the spleen, and the portal oxygen saturation isgenerally reduced. The portal pressure and flow may be reducedbelow critical bleeding levels, but patients like this, even in the bestof circumstances, may still be left with residual varices. These pa-tients are candidates for elective sclerotherapy of the varices. Theadvantage is that one does not have spurting varices when the esopha-goscope is introduced, and the flow is at least slowed, so thatsclerotherapy seldom requires more than one series of injections.

Dr. Terblanche, how long do you leave in the Sengstaken tube?Is this necessary for some degree of thrombosis and to slow thebleeding, and then go on with the sclerotherapy, or do you im-mediately do the sclerotherapy on an acute basis as soon as youremove the Sengstaken tube, or is that just a temporary expedient?Have you had any experience with bleeding gastric varices? Does

sclerosis of the esophageal varices slow down the bleeding lowerin the fundus of the stomach?

DR. OLGA JONASSON (Chicago, Illinois): After Professor Ter-blanche's visit to Cook County Hospital in 1978, we began to useendoscopic sclerotherapy just as described by him in our patientswith acute variceal hemorrhage.

(slide) During the first two years ofour experience, Dr. Palani in mydepartment sclerosed 22 acutely bleeding patients during 24 hospitaladmissions. Three-quarters of our patients were Class C, and nonewere Class A, and most demonstrated some degree of hepatic en-cephalopathy and liver dysfunction at the time of admission to thehospital.Bleeding was immediately controlled in most patients, and the

in-hospital mortality rate was reduced from nearly 75% for con-servative therapy only to 29% in the sclerosed patients. An observa-tion I found especially striking was how quickly the patients withvrXcephalopathy and hepatic dysfunction recover when the bleeding