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

Sachin Wani, Daniel Mullady, Dayna S. Early, Amit Rastogi, Brian Collins, Jeff F. Wang, Carrie Marshall, Sharon B. Sams, Roy Yen, Mona Rizeq, Maria Romanas, Ozlem Ulusarac, Brian Brauer, Augustin Attwell, Srinivas Gaddam, Thomas G. Hollander, Lindsay Hosford, Sydney Johnson, Vladimir Kushnir, Stuart K. AmateauCara Kohlmeier, Riad R. Azar, John Vargo, Norio Fukami, Raj J. Shah, Ananya Das, Steven A. Edmundowicz

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1429-1439
Number of pages11
JournalThe American journal of gastroenterology
Volume110
Issue number10
DOIs
StatePublished - Oct 1 2015
Externally publishedYes

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Endoscopic Ultrasound-Guided Fine Needle Aspiration
Randomized Controlled Trials
Endosonography
Fine Needle Biopsy
Neoplasms
Costs and Cost Analysis
Random Allocation

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

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; Mullady, Daniel; Early, Dayna S.; Rastogi, Amit; Collins, Brian; Wang, Jeff F.; Marshall, Carrie; Sams, Sharon B.; Yen, Roy; Rizeq, Mona; Romanas, Maria; Ulusarac, Ozlem; Brauer, Brian; Attwell, Augustin; Gaddam, Srinivas; Hollander, Thomas G.; Hosford, Lindsay; Johnson, Sydney; Kushnir, Vladimir; Amateau, Stuart K.; Kohlmeier, Cara; Azar, Riad R.; Vargo, John; Fukami, Norio; Shah, Raj J.; Das, Ananya; Edmundowicz, Steven A.

In: The American journal of gastroenterology, Vol. 110, No. 10, 01.10.2015, p. 1429-1439.

Research output: Contribution to journalArticle

Wani, S, Mullady, D, Early, DS, Rastogi, A, Collins, B, Wang, JF, Marshall, C, Sams, SB, Yen, R, Rizeq, M, Romanas, M, Ulusarac, O, Brauer, B, Attwell, A, Gaddam, S, Hollander, TG, Hosford, L, Johnson, S, Kushnir, V, Amateau, SK, Kohlmeier, C, Azar, RR, Vargo, J, Fukami, N, Shah, RJ, Das, A & Edmundowicz, SA 2015, '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', The American journal of gastroenterology, vol. 110, no. 10, pp. 1429-1439. https://doi.org/10.1038/ajg.2015.262
Wani, Sachin ; Mullady, Daniel ; Early, Dayna S. ; Rastogi, Amit ; Collins, Brian ; Wang, Jeff F. ; Marshall, Carrie ; Sams, Sharon B. ; Yen, Roy ; Rizeq, Mona ; Romanas, Maria ; Ulusarac, Ozlem ; Brauer, Brian ; Attwell, Augustin ; Gaddam, Srinivas ; Hollander, Thomas G. ; Hosford, Lindsay ; Johnson, Sydney ; Kushnir, Vladimir ; Amateau, Stuart K. ; Kohlmeier, Cara ; Azar, Riad R. ; Vargo, John ; Fukami, Norio ; Shah, Raj J. ; Das, Ananya ; Edmundowicz, Steven A. / 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. In: The American journal of gastroenterology. 2015 ; Vol. 110, No. 10. pp. 1429-1439.
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abstract = "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.",
author = "Sachin Wani and Daniel Mullady and Early, {Dayna S.} and Amit Rastogi and Brian Collins and Wang, {Jeff F.} and Carrie Marshall and Sams, {Sharon B.} and Roy Yen and Mona Rizeq and Maria Romanas and Ozlem Ulusarac and Brian Brauer and Augustin Attwell and Srinivas Gaddam and Hollander, {Thomas G.} and Lindsay Hosford and Sydney Johnson and Vladimir Kushnir and Amateau, {Stuart K.} and Cara Kohlmeier and Azar, {Riad R.} and John Vargo and Norio Fukami and Shah, {Raj J.} and Ananya Das and Edmundowicz, {Steven A.}",
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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.

PY - 2015/10/1

Y1 - 2015/10/1

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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