A prospective, single-blind, randomized, controlled trial of EUS-guided FNA with and without a...

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ORIGINAL ARTICLE: Clinical Endoscopy A prospective, single-blind, randomized, controlled trial of EUS-guided FNA with and without a stylet Amit Rastogi, MD, Sachin Wani, MD, Neil Gupta, MD, Vikas Singh, MD, Srinivas Gaddam, MD, Savio Reddymasu, MD, Ozlem Ulusarac, MD, Fang Fan, MD, Maria Romanas, MD, Katie L. Dennis, MD, Prateek Sharma, MD, Ajay Bansal, MD, Melissa Oropeza-Vail, RN, Mojtaba Olyaee, MD Kansas City, Kansas, USA Background: Most endosonographers use an EUS needle with an internal stylet during EUS-guided FNA (EUS-FNA). Reinserting the stylet into the needle after every pass is tedious and time-consuming, and there are no data to suggest that it improves the quality of the cytology specimen. Objective: To compare the samples obtained by EUS-FNA with and without a stylet for (1) the degree of cellularity, adequacy, contamination, and amount of blood and (2) the diagnostic yield of malignancy. Design: Prospective,single-blind, randomized, controlled trial. Setting: Two tertiary care referral centers. Patients: Patients referred for EUS-FNA of solid lesions. Intervention: Patients underwent EUS-FNA of the solid lesions, and 2 passes each were made with a stylet and without a stylet in the needle. The order of the passes was randomized, and the cytopathologists reviewing the slides were blinded to the stylet status of passes. Main Outcome Measurements: Degree of cellularity, adequacy, contamination, amount of blood, and the diagnostic yield of malignancy in the specimens. Results: A total of 101 patients with 118 lesions were included in final analysis; 236 FNA passes were made, each with and without a stylet. No significant differences were seen in the cellularity (P .98), adequacy of the specimen (P .26), contamination (P .92), or significant amount of blood (P .61) between specimens obtained with and without a stylet. The diagnostic yield of malignancy was 55 of 236 specimens (23%) in the with-stylet group compared with 66 of 236 specimens (28%) in the without-stylet group (P .29). Limitations: Endosonographers were not blinded to the stylet status of the passes. Conclusions: Using a stylet during EUS-FNA does not confer any significant advantage with regard to the quality of the specimen obtained or the diagnostic yield of malignancy. (Clinical trial registration number: NCT 01213290). ( Gastrointest Endosc 2011;74:58-64.) EUS and EUS-guided FNA (EUS-FNA) have emerged as safe and accurate modalities for the diagnosis and staging of GI and certain non-GI malignancies. 1 Real-time tissue sampling by EUS-FNA can provide expedited diagnostic and prognostic information relating to the presence or absence of malignancy, as well as the staging. 2,3 Several factors can affect the diagnostic yield and accuracy of EUS-FNA such as the skill and experience of the en- dosonographer, the presence of an on-site cytopatholo- gist, the diameter of the needle, the use of suction during Abbreviation: EUS-FNA, EUS-guided FNA. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. Copyright © 2011 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 doi:10.1016/j.gie.2011.02.015 Received December 13, 2010. Accepted February 16, 2011. Current affiliations: Veterans Affairs Medical Center (A.R., S.W., N.G., V.S., S.G., S.R., O.U., M.R., P.S., A.B.), University of Kansas School of Medicine (A.R., S.W., N.G., S.R., F.F., K.L.D., P.S., A.B., M.O.-V., M.O.), Kansas City, Kansas, USA. Presented at the Annual Scientific Meeting of the American College of Gastroenterology, 2010, San Antonio, Tex. Reprint requests: Amit Rastogi, MD, University of Kansas School of Medicine, Gastroenterology (111), Kansas City Veterans Affairs Medical Center, 4801 E. Linwood Blvd., Kansas City, MO 64128-2295. If you would like to chat with an author of this article, you may contact Dr. Rastogi at [email protected]. 58 GASTROINTESTINAL ENDOSCOPY Volume 74, No. 1 : 2011 www.giejournal.org

Transcript of A prospective, single-blind, randomized, controlled trial of EUS-guided FNA with and without a...

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ORIGINAL ARTICLE: Clinical Endoscopy

A prospective, single-blind, randomized, controlled trial of EUS-guidedFNA with and without a stylet

Amit Rastogi, MD, Sachin Wani, MD, Neil Gupta, MD, Vikas Singh, MD, Srinivas Gaddam, MD,Savio Reddymasu, MD, Ozlem Ulusarac, MD, Fang Fan, MD, Maria Romanas, MD, Katie L. Dennis, MD,Prateek Sharma, MD, Ajay Bansal, MD, Melissa Oropeza-Vail, RN, Mojtaba Olyaee, MD

Kansas City, Kansas, USA

Background: Most endosonographers use an EUS needle with an internal stylet during EUS-guided FNA(EUS-FNA). Reinserting the stylet into the needle after every pass is tedious and time-consuming, and there areno data to suggest that it improves the quality of the cytology specimen.

Objective: To compare the samples obtained by EUS-FNA with and without a stylet for (1) the degree ofcellularity, adequacy, contamination, and amount of blood and (2) the diagnostic yield of malignancy.

Design: Prospective,single-blind, randomized, controlled trial.

Setting: Two tertiary care referral centers.

Patients: Patients referred for EUS-FNA of solid lesions.

Intervention: Patients underwent EUS-FNA of the solid lesions, and 2 passes each were made with a stylet andwithout a stylet in the needle. The order of the passes was randomized, and the cytopathologists reviewing theslides were blinded to the stylet status of passes.

Main Outcome Measurements: Degree of cellularity, adequacy, contamination, amount of blood, and thediagnostic yield of malignancy in the specimens.

Results: A total of 101 patients with 118 lesions were included in final analysis; 236 FNA passes were made, eachwith and without a stylet. No significant differences were seen in the cellularity (P � .98), adequacy of thespecimen (P � .26), contamination (P � .92), or significant amount of blood (P � .61) between specimensobtained with and without a stylet. The diagnostic yield of malignancy was 55 of 236 specimens (23%) in thewith-stylet group compared with 66 of 236 specimens (28%) in the without-stylet group (P � .29).

Limitations: Endosonographers were not blinded to the stylet status of the passes.

Conclusions: Using a stylet during EUS-FNA does not confer any significant advantage with regard to the qualityof the specimen obtained or the diagnostic yield of malignancy. (Clinical trial registration number: NCT01213290). (Gastrointest Endosc 2011;74:58-64.)

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EUS and EUS-guided FNA (EUS-FNA) have emerged assafe and accurate modalities for the diagnosis and stagingof GI and certain non-GI malignancies.1 Real-time tissueampling by EUS-FNA can provide expedited diagnosticnd prognostic information relating to the presence or

Abbreviation: EUS-FNA, EUS-guided FNA.

DISCLOSURE: All authors disclosed no financial relationships relevant tohis publication.

opyright © 2011 by the American Society for Gastrointestinal Endoscopy016-5107/$36.00oi:10.1016/j.gie.2011.02.015

eceived December 13, 2010. Accepted February 16, 2011.

urrent affiliations: Veterans Affairs Medical Center (A.R., S.W., N.G., V.S.,

.G., S.R., O.U., M.R., P.S., A.B.), University of Kansas School of Medicine R

58 GASTROINTESTINAL ENDOSCOPY Volume 74, No. 1 : 2011

bsence of malignancy, as well as the staging.2,3 Severalactors can affect the diagnostic yield and accuracy ofUS-FNA such as the skill and experience of the en-osonographer, the presence of an on-site cytopatholo-ist, the diameter of the needle, the use of suction during

A.R., S.W., N.G., S.R., F.F., K.L.D., P.S., A.B., M.O.-V., M.O.), Kansas City,ansas, USA.

resented at the Annual Scientific Meeting of the American College ofastroenterology, 2010, San Antonio, Tex.

eprint requests: Amit Rastogi, MD, University of Kansas School of Medicine,astroenterology (111), Kansas City Veterans Affairs Medical Center, 4801 E.inwood Blvd., Kansas City, MO 64128-2295.

f you would like to chat with an author of this article, you may contact Dr.

astogi at [email protected].

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FNA, and the number of passes.4-10 Conventionally, mostndosonographers use an EUS needle with an internaltylet during EUS-FNA. The use of this removable stylet isased on the theoretical belief that it helps prevent clog-ing of the lumen of the needle by the GI wall tissue as theeedle traverses this to reach the target lesion. Blockage ofhe needle with gut wall tissue can impair the ability tospirate cells from the target lesion and thus negativelyffect the quality and the diagnostic yield of the specimenbtained by EUS-FNA. Although this assumption favoringhe use of a stylet seems logical, there is no concretevidence supporting its use during EUS-FNA. Moreover,he use of a stylet is labor-intensive and time-consumingnd makes the procedure more tedious because the styletust be withdrawn after puncturing the lesion and then

einserted into the needle before the next pass.11

The aims of this study were to compare the samplesobtained by EUS-FNA with and without a stylet for (1) the de-gree of cellularity, adequacy, contamination, and amount ofblood and (2) the diagnostic yield of malignancy.

METHODS

DesignThis was a prospective, single-blind, randomized, con-

trolled trial conducted at 2 tertiary care referral centers.The study was approved by the local institutional reviewboard at both centers.

Study populationPatients referred for EUS-FNA of solid lesions were

prospectively enrolled in this study. Patients were enrolledfrom August 2009 to May 2010. Written informed consentwas obtained from all patients. The inclusion criteria wereage older than 18 years, ability to provide informed con-sent, and the presence of a solid lesion-like mediastinal orintra-abdominal lymph nodes or mass, solid pancreaticmass, left adrenal mass, GI submucosal lesion, or liverlesion confirmed by at least a single investigational mo-dality like CT, magnetic resonance imaging, and endos-copy. The exclusion criteria were severe coagulopathy(international normalized ratio �1.5) or thrombocytope-nia (platelet count �50,000), inability to sample the lesionbecause of the presence of intervening blood vessels,results of EUS-FNA would not affect patient management,and the inability to provide informed consent.

EUS-FNA procedureAll procedures were performed by 2 experienced en-

dosonographers (A.R. and M.O.). The curvilinear arrayechoendoscope (GF-UC140P or GF-UCT140; OlympusMedical Systems, Center Valley, Pa, or EG-3630U; Pentax,Montvale, NJ) were used. The procedures were performedwith the patients in the left lateral position under moderatesedation with intravenous midazolam and intravenous me-

peridine or fentanyl or intravenous propofol. The location, d

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ize, shape, margins (regular, irregular, well defined, poorlyefined), and echogenicity of the lesions were recorded oncase report form. After localizing the lesion, a 22-gaugeeedle (EUS N-3; Cook Medical, Winston Salem, NC) wassed for EUS-FNA. For the passes made with a stylet, theatter was left inside the needle, slightly retracted from theip. After puncturing the lesion, the stylet was pushed ineyond the needle tip and then removed. If the next passas also designated to be with the stylet, then it was

einserted in the needle. For passes made without a stylet,here was no stylet in the needle throughout that entireass. For all passes, the needle was passed through the GIract wall into the lesion followed by approximately 10 to2 backward and forward movements while keeping theeedle tip in the lesion. Continuous suction using a 10-mLyringe was applied. This was turned off before withdraw-ng the needle from the lesion.

andomizationEach lesion was sampled for a minimum of 4 needle

asses: 2 passes with a stylet in place and 2 without atylet. The order of these passes was determined by areprinted randomization sequence kept in an opaqueealed envelope that was opened by a research coordina-or after enrollment.

ytopathologyEach procedure was performed with a cytopathologist

r cytotechnologist in the room. After each pass, the sam-le from the needle was expressed using a 10-mL air-filledyringe onto a glass slide until no further material could bexpressed. Then using another glass slide, the sample waspread out to make 2 slides. These slides were numberedccording to the number of the pass. One slide was airried and stained with Diff-Quik stain for immediate on-ite interpretation. The other slide was fixed in alcohol95% ethanol) and stained later with Papanicolaou stain.he residual contents of the needle after every pass wereushed with 5 to 10 mL of sterile saline solution into theaccomano or cytolyte solution. After flushing the needle, thexterior of the needle was wiped with sterile gauze soaked inaline solution to reduce cross-contamination between theasses. There was no communication between the en-

Take-home Message

● This randomized, controlled trial showed no significantdifferences between the specimens obtained by EUS-FNAwith and without a stylet with regard to cellularity,adequacy of the specimen, contamination, significantamount of blood, and diagnostic yield of malignancy.

● If these findings are confirmed by other studies, then theuse of a stylet can be avoided during EUS-FNA.

osonographer and the cytopathologist regarding the ade-

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quacy of the specimen or diagnosis until all 4 passes hadbeen completed. The on-site evaluation of smears was per-formed to assess cellular adequacy and to assess the need forany additional passes, ie, after the first 4 passes.

The cytology slides were evaluated by 4 cytopatholo-gists who were all blinded to the stylet status of the passes.All of the slides from 1 patient were evaluated by 1 cyto-pathologist. The slides for each pass were assessed using

TABLE 1. Cytological results of samples obtained with and with

Parameter

Cellularity

% area of slide that contains cells of the representative lesion

No representative cells present

Representative cells present in �25% of the slide

Representative cells present in �25%-50% of the slide

Representative cells present in �50 % of the slide

No. of cells per slide

Fair (�100 cells/slide)

Good (100-1000 cells/slide)

Excellent (�1000 cells/slide)

Adequacy of specimen

Inadequate

Adequate

Contamination

% area of slide that represents GI contamination

No contaminations seen

Contamination present in �25% of the slide

Contamination present in 25%-50% of the slide

Contamination present in �50% of the slide

Amount of blood

Minimal

Moderate

Significant

Diagnosis

Benign

Atypical

Suspicious

Malignant

Inadequate for reporting

strict predefined criteria for the following (Table 1): cellu- A

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arity, adequacy of the specimen, contamination, amountf blood, and diagnosis. These criteria were agreed on byonsensus of the 4 cytopathologists and were describedreviously.12 The final diagnosis of malignancy was madey reviewing all of the slides prepared from the lesion byasses made with and without the stylet, any additionalasses, as well as from the cell block. The results werentered on a case report form and then transferred to an

tylet

With a stylet(n � 236)

Without a stylet(n � 236) P value

.97

74 (31%) 70 (30%)

84 (36%) 84 (35%)

42 (18%) 45 (19%)

36 (15%) 37 (16%)

.99

116 (49%) 118 (50%)

73 (31%) 72 (31%)

46 (20%) 46 (19%)

.26

102 (43%) 89 (38%)

133 (57%) 146 (62%)

.92

83 (35%) 79 (33%)

115 (49%) 122 (52%)

32 (14%) 30 (13%)

6 (2%) 5 (2%)

119 (50%) 96 (41%) .04

78 (33%) 105 (45%) .01

39 (17%) 34 (14%) .61

.75

38 (16%) 41 (17%)

28 (12%) 24 (10%)

18 (8%) 18 (8%)

55 (23%) 66 (28%)

97 (41%) 87 (37%)

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Outcome variablesThe primary outcome of this study was the degree of

cellularity, adequacy, contamination, and amount of bloodin the samples obtained by EUS-FNA with and without thestylet. The secondary outcome was the diagnostic yield ofmalignancy in the specimens obtained by EUS-FNA withand without stylet.

Statistical analysisA target sample size of 100 patients was decided a

priori. Lack of good prospective data comparing the 2techniques (EUS-FNA with and without stylet) precludedus from making formal assumptions to calculate a validsample size. We assumed that a sample size of 100 patientswould provide enough pilot data that can be used toconduct larger multicenter, randomized trials in the future.If EUS-FNA was performed on more than 1 lesion in apatient, then for statistical analysis, these lesions wereconsidered as independent observations. The statisticalsoftware program STATA/IC version 10.1 (StataCorp, Col-lege Station, Tex) was used for analysis. The Fisher exacttest was used to compare categorical variables for analysisbased on individual FNA passes such as degree of cellularity,contamination, amount of blood, adequacy of sample, and

Figure 1. Enro

final diagnosis. McNemar’s test was used to compare paired m

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ategorical data when 2 outcomes were possible. A 2-sided Palue �.05 was considered significant. The results are re-orted in accordance to the CONSORT 2010 statement13 andtandards for Reporting of Diagnostic Accuracy (STARD)uidelines.14

ESULTS

atients and lesionsA total of 109 patients were enrolled from August 2009

o May 2010 (Fig. 1). Eight patients were excluded; 6atients took their cytology slides for review to anothernstitution before they could be reviewed for the study andpatients underwent only 3 FNA passes. Of the 101 pa-

ients included in this analysis, 70 (69%) were males, 8685%) were white, 11 (11%) were African Americans, and

(4%) were Hispanics. The mean age was 63.1 yearsstandard deviation 13.8). A total of 118 lesions underwentUS-FNA: 61 pancreatic masses (52%), 31 lymph nodes26%), 6 liver lesions (5%), 5 left adrenal masses (4%), and5 others (13%) (1 submucosal lesion in the esophagus, 4astric submucosal lesions, 1 rectal submucosal lesion, 2mpullary masses, 5 peripancreatic or porta hepatisasses, 1 right lung mass, 1 retroperitoneal mass). The

nt of patients.

ean size of the lesions was 2.75 cm (standard deviation

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1.8 cm). The shape of the lesions was irregular in 43 (36%),round in 36 (31%), oval in 34 (29%), and triangular in 5(4%). The margins of the lesions were regular in 70 (59%)and irregular in 48 (41%). A total of 89 lesions (75%) werehypoechoic. The final cytological diagnosis was malignantin 55 lesions (47%), suspicious for malignancy in 8 lesions(6%), atypical cells in 15 lesions (13%), benign in 27lesions (23%), and inadequate sample in 13 lesions (11%).In all lesions, at least 2 passes were made with a stylet and2 without a stylet. Hence, a total of 236 passes with a styletwere compared with 236 passes made without a stylet.There were no instances of needle malfunction or clog-ging reported during this study.

CytopathologyNo significant differences were seen in the cellularity

(P � .98), adequacy of the specimen (P � .26), contami-nation (P � 0.92), and significant amount of blood (P �.61) between the specimens obtained with and without astylet (Table 1). The EUS-FNA with-stylet group had ahigher proportion of specimens with minimal amount ofblood (P � .04) and a lower proportion of specimens witha moderate amount of blood (P � .01) compared withEUS-FNA without a stylet.

Diagnostic yield of malignancy was 55 of 236 speci-mens (23%) in the with-stylet group compared with 66 of236 specimens (28%) in the without-stylet group (P � .29).Similarly, if specimens diagnosed as suspicious for malig-nancy were included in the malignant group, then alsothere was no significant difference seen between the 2groups (with stylet: 73/236 [31%] vs without stylet: 84/236[36%], P � .33).

A final diagnosis of malignancy was made in 55 of 118lesions (47%). Per-lesion analysis shows that in the with-stylet group, diagnosis of malignancy was made in 35 ofthese 55 lesions (64%), whereas in the without-styletgroup, it was made in 43 of these 55 lesions (78%) (P �.13). Therefore, 20 malignant lesions (36%) were missedby the with-stylet passes, whereas only 12 (22%) weremissed by the without-stylet passes. This difference wasnot statistically significant (P � .13). Twenty-eight of the55 malignant lesions (51%) were diagnosed as malignantby both EUS-FNA techniques. Of the 20 malignant lesionsmissed by the with-stylet passes, 14 were pancreatic can-cers, 2 were malignant lymph nodes, and 4 were others.Of the 12 malignant lesions missed by the without-styletpasses, 6 were pancreatic cancers, 2 were malignantlymph nodes, and 4 were others. If the lesions diag-nosed as suspicious for malignancy were included inthe malignant category, then a total of 63 of 118 lesions(53%) would be deemed malignant. Of these, 49 lesions(78%) would have been diagnosed in the with-styletgroup, whereas 50 (80%) would have been diagnosed inthe without-stylet group (P � 1.00). Therefore, 14malignant/suspicious lesions were missed by the with-

stylet passes and 13 were missed by the without-stylet s

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asses. Forty-two of these lesions were diagnosed asalignant or suspicious by both techniques.Furthermore, we compared the cellularity, adequacy of

he specimen, contamination, amount of blood, and diag-ostic yield of malignancy between the specimens ob-ained with and without a stylet from different types ofesions, ie, pancreas, lymph nodes, and others. For the 61ancreatic masses, there were no significant differenceseen in the cellularity (P � .26), adequacy of the specimenP � .23), contamination (P � .58), significant amount oflood (P � 1.0), and diagnostic yield of malignancy (P �30) between 122 specimens obtained each with and with-ut a stylet. Similarly, for lymph nodes, there were noignificant differences seen in the cellularity (P � .35),dequacy of the specimen (P � .85), contamination (P �75), significant amount of blood (P � .68), and the diag-ostic yield of malignancy (P � .69) between the speci-ens obtained with and without a stylet. Last, for the restf the lesions combined, there were also no significantifferences seen in the cellularity (P � .93), adequacy ofhe specimen (P � .44), contamination (P � .50), signifi-ant amount of blood (P � .78), and the diagnostic yield ofalignancy (P � .78) between the specimens obtainedith and without a stylet.

ISCUSSION

EUS-FNA is being increasingly used for the diagnosisnd staging of both GI and non-GI malignancies. Althoughhe technique of EUS-FNA and the type of needle usedaries between different endosonographers, most still usestylet in the needle. The use of a stylet is based on

onventional wisdom that it improves the quality of spec-mens obtained and hence the diagnostic yield. This isased on the premise that a stylet prevents clogging of theumen of the needle by the GI wall tissue as the needleraverses this. There are, however, no data to suggest thathe use of a stylet is beneficial in any way. Moreover, therere several disadvantages to using a stylet. Reinserting thetylet in the needle after every pass is time-consuming,edious, and cumbersome for the technician assisting withhe procedure. It may also increase the risk of uninten-ional needle stick injury. In certain situations, it may beifficult, if not impossible, to advance or remove the styletnce the target lesion has been punctured, especially ifhere is a loop in the echoendoscope, the needle is bent,r a 19-gauge needle is being used. Reinserting the styletn the needle can become increasingly difficult with eachass if there is a kink or a bend in the needle sheath.We conducted a prospective, single-blind, randomized,

ontrolled trial to compare the specimens obtained byUS-FNA with and without a stylet for the degree ofellularity, adequacy, contamination, amount of blood,nd diagnostic yield of malignancy. All slides were re-iewed by cytopathologists who were blinded to the stylet

tatus. A total of 236 passes each were made with and

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without a stylet in 118 lesions. The cytological character-istics were compared using well-defined comprehensivecriteria. No significant differences were seen in the cellu-larity (P � .98), adequacy of the specimen (P � .26), andcontamination (P � .92) between specimens obtained

ith and without a stylet. EUS-FNA in the without-styletroup had a lower proportion of specimens with minimalmount of blood and a higher proportion of specimensith a moderate amount of blood compared with theith-stylet group. However, there was no difference in the

ignificant amount of blood (P � .61) between specimensbtained by the 2 techniques. Although the diagnosticield of malignancy was higher in the passes made with-ut a stylet by 14%, the difference was not statisticallyignificant (P � .13). Our results thus challenge the prem-se that using a stylet during EUS-FNA improves the qualityr diagnostic yield of specimen obtained.

There are limited data comparing EUS-FNA with andithout a stylet. In a recent study, Sahai et al11 compared

he yield of malignancy and quality of the specimensbtained during EUS-FNA with and without a stylet. A totalf 135 lesions in 111 patients were sampled by a singlendosonographer using a 22-gauge needle with a system-tic assignment of with and without stylet passes in a 1:2atio. All slides in this study were read by a single, blindedytopathologist for bloodiness, adequacy, and presence ofalignancy. The proportion of adequate samples was

ower (75% vs 87%, P � .013) and the proportion ofbloody samples higher (75% vs 52%, P � .0001) in thewith-stylet group compared with the without-stylet group.Therefore, in this study, the use of a stylet was actuallyassociated with an inferior sample quality. In 46 lesions inwhich an equal number of passes was made with andwithout a stylet, the yield for malignancy was similar in the2 techniques. The investigators thus questioned the valueand utility of using a stylet during EUS-FNA. Because thisstudy used the needles manufactured by Olympus, theconclusions appear to be valid for needles from differentmanufacturers. Another retrospective study, still in abstractform,15 compared the yield and number of passes requiredto obtain adequate samples among cases with and withouta stylet. A total of 54 sites in 47 consecutive patients weresampled with a 25-gauge needle, and no differences wereseen in the cellularity, contamination, and diagnostic yieldin the 2 techniques. In an earlier study from our institu-tion,12 we retrospectively compared the quality of thespecimens and the diagnostic yield of malignancy be-tween samples obtained with and without a stylet. EUS-FNA procedures were performed with a stylet (106 le-sions) and without a stylet (122 lesions) in 2 different timeperiods. The slides were retrieved, de-identified, and eval-uated by 2 cytopathologists blinded to the FNA technique.No significant differences were seen in the 2 techniques inthe cellularity (P � .37), contamination (P � .18), signifi-cant amount of blood (P � .42), and adequacy of the

specimen (P � .45). Furthermore, the diagnostic yield of

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alignancy was not different (P � .48). Another prospec-ive study, still in abstract form,16 in 37 patients withancreatic mass showed no difference in the adequacy ofhe specimen obtained with and without a stylet. Thus,here is growing evidence suggesting the futility of using atylet during EUS-FNA, whereas there are no data to sup-ort its use.Our study has a few limitations. Although we used very

omprehensive, predefined criteria to assess the cytologi-al characteristics of the specimens obtained with andithout a stylet, there remains subjectivity in their assess-ent by the cytopathologists. However, all of the slides

rom 1 patient were evaluated by 1 cytopathologist whoas blinded to the stylet status of the passes. Hence, allytopathologists evaluated equal numbers of slides ob-ained by the 2 techniques. We did not assess for thenterobserver agreement among the cytopathologists inhe assessment of EUS-FNA specimens. Only 22-gaugeeedles were used in this study, and hence the results mayot be generalizable to needles of other sizes (19 or 25auge). Continuous suction was used for all passes, andhis may have affected the amount of blood. The en-osonographers were not blinded to the stylet status ofach pass, as logistically this was not possible. Deliberatefforts were made, however, to ensure that apart from these of a stylet, there was no difference in the technique forach of the 4 passes made in the lesion. We did not followhe patients longitudinally to address the issue of sensitiv-ty, specificity, and accuracy of the 2 techniques in detect-ng malignancy.

In conclusion, this prospective, randomized, con-rolled, single-blind study shows that using a stylet duringUS-FNA does not confer any significant advantage withegard to the quality of the specimen obtained or theiagnostic yield of malignancy. If these results are con-rmed by endosonographers at other centers, it would beeasonable not to use a stylet during EUS-FNA, potentiallyaking the procedure less tedious and more efficient.

EFERENCES

1. Erickson RA. EUS-guided FNA. Gastrointest Endosc 2004;60:267-79.2. Kulesza P, Eltoum IA. Endoscopic ultrasound-guided fine-needle aspira-

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