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.
OBJECTIVE
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.
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.|Veterans Affairs Medical Center, Denver, Colorado, USA.
Sachin
S
Wani
Washington University School of Medicine, St Louis, Missouri, USA.
Daniel
D
Mullady
Washington University School of Medicine, St Louis, Missouri, USA.
Dayna S
DS
Early
University of Kansas School of Medicine and Veterans Affairs Medical Center, Kansas City, Missouri, USA.
Amit
A
Rastogi
Washington University School of Medicine, St Louis, Missouri, USA.
Brian
B
Collins
Washington University School of Medicine, St Louis, Missouri, USA.
Jeff F
JF
Wang
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.
Carrie
C
Marshall
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.
Sharon B
SB
Sams
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.
Roy
R
Yen
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.|Veterans Affairs Medical Center, Denver, Colorado, USA.
Mona
M
Rizeq
University of Kansas School of Medicine and Veterans Affairs Medical Center, Kansas City, Missouri, USA.
Maria
M
Romanas
University of Kansas School of Medicine and Veterans Affairs Medical Center, Kansas City, Missouri, USA.
Ozlem
O
Ulusarac
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.
Brian
B
Brauer
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.
Augustin
A
Attwell
Washington University School of Medicine, St Louis, Missouri, USA.
Srinivas
S
Gaddam
Washington University School of Medicine, St Louis, Missouri, USA.
Thomas G
TG
Hollander
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.
Lindsay
L
Hosford
University of Kansas School of Medicine and Veterans Affairs Medical Center, Kansas City, Missouri, USA.
Sydney
S
Johnson
Washington University School of Medicine, St Louis, Missouri, USA.
Vladimir
V
Kushnir
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.
Stuart K
SK
Amateau
Washington University School of Medicine, St Louis, Missouri, USA.
Cara
C
Kohlmeier
Washington University School of Medicine, St Louis, Missouri, USA.
Riad R
RR
Azar
Cleveland Clinic, Cleveland, Ohio, USA.
John
J
Vargo
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.
Norio
N
Fukami
Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.
Raj J
RJ
Shah
Arizona Center for Digestive Health, Gilbert, Arizona, USA.
Ananya
A
Das
Washington University School of Medicine, St Louis, Missouri, USA.
Steven A
SA
Edmundowicz
D000368:Aged; D001706:Biopsy; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000379:methods* / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010182:Pancreatic Diseases / Q000175:diagnosis / Q000473:pathology; D010190:Pancreatic Neoplasms / Q000175:diagnosis / Q000473:pathology*; D010338:Pathology, Clinical / Q000379:methods* / Q000706:statistics & numerical data; D012680:Sensitivity and Specificity