TY - JOUR
T1 - The clinical impact of immediate on-site cytopathology evaluation during endoscopic ultrasound-guided fine needle aspiration of pancreatic masses
T2 - A prospective multicenter randomized controlled trial
AU - Wani, Sachin
AU - Mullady, Daniel
AU - Early, Dayna S.
AU - Rastogi, Amit
AU - Collins, Brian
AU - Wang, Jeff F.
AU - Marshall, Carrie
AU - Sams, Sharon B.
AU - Yen, Roy
AU - Rizeq, Mona
AU - Romanas, Maria
AU - Ulusarac, Ozlem
AU - Brauer, Brian
AU - Attwell, Augustin
AU - Gaddam, Srinivas
AU - Hollander, Thomas G.
AU - Hosford, Lindsay
AU - Johnson, Sydney
AU - Kushnir, Vladimir
AU - Amateau, Stuart K.
AU - Kohlmeier, Cara
AU - Azar, Riad R.
AU - Vargo, John
AU - Fukami, Norio
AU - Shah, Raj J.
AU - Das, Ananya
AU - Edmundowicz, Steven A.
N1 - Publisher Copyright:
© 2015 by the American College of Gastroenterology
PY - 2015/10
Y1 - 2015/10
N2 - 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.
AB - 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.
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U2 - 10.1038/ajg.2015.262
DO - 10.1038/ajg.2015.262
M3 - Article
C2 - 26346868
AN - SCOPUS:85028197869
SN - 0002-9270
VL - 110
SP - 1429
EP - 1439
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 10
ER -