Diagnostic yield of malignancy during EUS-guided FNA of solid lesions with and without a stylet: A prospective, single blind, randomized, controlled trial

Sachin Wani, Dayna Early, Julie Kunkel, Ann Leathersich, Christine E. Hovis, Thomas G. Hollander, Cara Kohlmeier, Cynthia Zelenka, Riad Azar, Steven Edmundowicz, Brian Collins, Jingxia Liu, Matthew Hall, Daniel Mullady

Research output: Contribution to journalArticlepeer-review

61 Scopus citations

Abstract

Background: Use of a stylet during EUS-guided FNA (EUS-FNA) is believed to improve the quality and diagnostic yield of specimens. Objective: To compare samples obtained by EUS-FNA with (S+) and without (S-) a stylet for diagnostic yield of malignancy and cytological characteristics. Design: Randomized, controlled trial. Setting: Tertiary referral center. Patients: Consecutive patients referred for EUS-FNA of solid lesions. Intervention: EUS-FNA; the number of passes was determined by lesion site (6 pancreas/others and 4 lymph nodes). Main Outcome Measurements: Diagnostic yield of malignancy and degree of cellularity, specimen adequacy, contamination, and amount of blood. Results: One hundred patients were prospectively enrolled in this randomized, controlled trial and the sites of EUS-FNA were the pancreas, 58; lymph node, 25; and other, 17. The overall diagnosis was malignancy in 56, benign in 30, suspicious/atypical in 7, and inadequate specimen in 7 lesions. There were 550 passes made (275 with a stylet and 275 without a stylet). Interim analysis demonstrated no difference in the diagnostic yield of malignancy (94 passes with a stylet [34.2%] vs 110 without a stylet [40%], P =.2) and in the proportion of inadequate specimens (57 with a stylet [20.7%] vs 64 without a stylet [23.3%], P =.2). There was no difference with regard to cellularity (P =.83), contamination (P =.31), number of cells (P =.25), and amount of blood (P =.6). Similar results were noted in a subgroup analysis based on lesion site. Applying the rules of futility, the study was terminated. Limitations: Subjectivity in cytopathologists' assessment, endosonographer not blinded. Conclusions: There was no difference in the diagnostic yield of malignancy or proportion of inadequate specimens between passes with and without a stylet. These results suggest that the use of a stylet does not confer any advantage during EUS-FNA. (Clinical trial registration number: NCT01316614.)

Original languageEnglish
Pages (from-to)328-335
Number of pages8
JournalGastrointestinal endoscopy
Volume76
Issue number2
DOIs
StatePublished - Aug 2012

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