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The Clinical Impact of Immediate On-Site Cytopathology Evaluation During Endoscopic Ultrasound-Guided Fine Needle Aspiration of Pancreatic Masses: A Prospective Multicenter Randomized Controlled Trial

Wani, Sachin MD1,2; Mullady, Daniel MD3; Early, Dayna S MD3; Rastogi, Amit MD4; Collins, Brian MD3; Wang, Jeff F MD3; Marshall, Carrie MD1; Sams, Sharon B MD,MPH1; Yen, Roy MD,MPH1; Rizeq, Mona MD1,2; Romanas, Maria MD4; Ulusarac, Ozlem MD4; Brauer, Brian MD1; Attwell, Augustin MD1; Gaddam, Srinivas MD3; Hollander, Thomas G MS3; Hosford, Lindsay BA1; Johnson, Sydney BA4; Kushnir, Vladimir MD3; Amateau, Stuart K MD,PhD1; Kohlmeier, Cara3; Azar, Riad R MD3; Vargo, John MD,MPH5; Fukami, Norio MD1; Shah, Raj J MD1; Das, Ananya MD6; Edmundowicz, Steven A MD3

American Journal of Gastroenterology: October 2015 - Volume 110 - Issue 10 - p 1429–1439
doi: 10.1038/ajg.2015.262
ORIGINAL CONTRIBUTIONS: ENDOSCOPY
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Objectives: Observational data on the impact of on-site cytopathology evaluation (OCE) during endoscopic ultrasonography-guided fine needle aspiration (EUS–FNA) of pancreatic masses have reported conflicting results. We aimed to compare the diagnostic yield of malignancy and proportion of inadequate specimens between patients undergoing EUS–FNA of pancreatic masses with and without OCE.

Methods: In this multicenter randomized controlled trial, consecutive patients with solid pancreatic mass underwent randomization for EUS–FNA with or without OCE. The number of FNA passes in the OCE+ arm was dictated by the on-site cytopathologist, whereas seven passes were performed in OCE− arm. EUS–FNA protocol was standardized, and slides were reviewed by cytopathologists using standardized criteria for cytologic characteristics and diagnosis.

Results: A total of 241 patients (121 OCE+, 120 OCE−) were included. There was no difference between the two groups in diagnostic yield of malignancy (OCE+ 75.2% vs. OCE− 71.6%,P=0.45) and proportion of inadequate specimens (9.8 vs. 13.3%,P=0.31). Procedures in OCE+ group required fewer EUS–FNA passes (median, OCE+ 4 vs. OCE− 7,P<0.0001). There was no significant difference between the two groups with regard to overall procedure time, adverse events, number of repeat procedures, costs (based on baseline cost-minimization analysis), and accuracy (using predefined criteria for final diagnosis of malignancy). There was no difference between the two groups with respect to cytologic characteristics of cellularity, bloodiness, number of cells/slide, and contamination.

Conclusions: Results of this study demonstrated no significant difference in the diagnostic yield of malignancy, proportion of inadequate specimens, and accuracy in patients with pancreatic mass undergoing EUS–FNA with or without OCE.

1Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA

2Veterans Affairs Medical Center, Denver, Colorado, USA

3Washington University School of Medicine, St Louis, Missouri, USA

4University of Kansas School of Medicine and Veterans Affairs Medical Center, Kansas City, Missouri, USA

5Cleveland Clinic, Cleveland, Ohio, USA

6Arizona Center for Digestive Health, Gilbert, Arizona, USA

Correspondence: Sachin Wani, MD, Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Mail Stop F735, 1635 Aurora Court, Rm 2.031, Aurora, Colorado 80045, USA. E-mail: sachinwani10@yahoo.com

SUPPLEMENTARY MATERIAL accompanies this paper at http://links.lww.com/AJG/B128, http://links.lww.com/AJG/B129

Received 07 April 2015; accepted 01 July 2015

Results of this study were presented in part as Oral Presentations, Digestive Disease Week 2013, Orlando and 2014, Chicago.

Guarantor of the article: Sachin Wani, MD.

Specific author contributions: S.W.: study concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis; obtained funding; administrative, technical, or material support; study supervision; D.M., D.S.E., A.R., B.C., J.F.W., C.M., S.B.S., R.Y., M.R., O.U., B.B., A.A., S.G., V.K., S.K.A., R.R.A., N.F., R.J.S., A.D., and S.A.E.: acquisition of data; analysis and interpretation of data; critical revision of the manuscript for important intellectual content; T.G.H., L.H., S.J., and C.K.: administrative, technical, or material support; J.V.: critical revision of the manuscript for important intellectual content.

Financial support: Supported by the American College of Gastroenterology Clinical Research Award ACG-CR-006-2011, Principal investigators—S.W.

Potential competing interests: None.

© The American College of Gastroenterology 2015. All Rights Reserved.
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