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Endoscopy 2022; 54(01): 4-12
DOI: 10.1055/a-1375-9775
Original article

Endoscopic ultrasound (EUS)-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid onsite evaluation in pancreatic lesions: a multicenter randomized trial

Yen-I Chen 
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Avijit Chatterjee
2   Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada
,
Robert Berger
3   Division of Gastroenterology, Moncton Hospital, Moncton, New Brunswick, Canada
,
Yonca Kanber
4   Department of Pathology, McGill University Health Centre, Montreal, Quebec, Canada
,
Jonathan Wyse
5   Division of Gastroenterology and Hepatology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
,
Eric Lam
6   Division of Gastroenterology and Hepatology, St-Paul Hospital, Vancouver, British Columbia, Canada
,
Ian Gan
7   Division of Gastroenterology and Hepatology, Vancouver General Hospital, Vancouver, British Columbia, Canada
,
Manon Auger
4   Department of Pathology, McGill University Health Centre, Montreal, Quebec, Canada
,
Sana Kenshil
2   Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada
,
Jennifer Telford
6   Division of Gastroenterology and Hepatology, St-Paul Hospital, Vancouver, British Columbia, Canada
,
Fergal Donnellan
7   Division of Gastroenterology and Hepatology, Vancouver General Hospital, Vancouver, British Columbia, Canada
,
James Quinlan
2   Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada
,
Gregory Lutzak
8   Division of Gastroenterology and Hepatology, Royal Alexandra Hospital, University of Alberta, Edmonton, Alberta, Canada
,
Fatma Alshamsi
2   Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada
,
Josee Parent
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Kevin Waschke
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Adel Alghamdi
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Jeffrey Barkun
9   Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada
,
Peter Metrakos
9   Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada
,
Prosanto Chaudhury
9   Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada
,
Myriam Martel
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Alastair Dorreen
2   Division of Gastroenterology and Hepatology, Ottawa Hospital, Ottawa University, Ottawa, Ontario, Canada
,
Kristen Candido
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Corey Miller 
5   Division of Gastroenterology and Hepatology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
,
Viviane Adam
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
Alan Barkun
1   Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
,
George Zogopoulos
9   Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada
,
Clarence Wong
8   Division of Gastroenterology and Hepatology, Royal Alexandra Hospital, University of Alberta, Edmonton, Alberta, Canada
› Author AffiliationsTrial Registration: ClinicalTrials.gov Registration number (trial ID): NCT03435588 Type of study: Multicenter randomized controlled trial
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With or without ROSE: does fine-needle biopsy settle the debate on rapid on-site evaluation?Endoscopy 2022; 54(01): 13-15
DOI: 10.1055/a-1513-0564

Abstract

Background Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the standard in the diagnosis of solid pancreatic lesions, in particular when combined with rapid onsite evaluation of cytopathology (ROSE). More recently, a fork-tip needle for core biopsy (FNB) has been shown to be associated with excellent diagnostic yield. EUS-FNB alone has however not been compared with EUS-FNA + ROSE in a large clinical trial. Our aim was to compare EUS-FNB alone to EUS-FNA + ROSE in solid pancreatic lesions.

Methods A multicenter, non-inferiority, randomized controlled trial involving seven centers was performed. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary end point was diagnostic accuracy. Secondary end points included sensitivity/specificity, mean number of needle passes, and cost.

Results 235 patients were randomized: 115 EUS-FNB alone and 120 EUS-FNA + ROSE. Overall, 217 patients had malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA + ROSE at 92.2 % (95 %CI 86.6 %–96.9 %) and 93.3 % (95 %CI 88.8 %–97.9 %), respectively (P = 0.72). Diagnostic sensitivity for malignancy was 92.5 % (95 %CI 85.7 %–96.7 %) for EUS-FNB alone vs. 96.5 % (93.0 %–98.6 %) for EUS-FNA + ROSE (P = 0.46), while specificity was 100 % in both. Adequate histological yield was obtained in 87.5 % of the EUS-FNB samples. The mean (SD) number of needle passes and procedure time favored EUS-FNB alone (2.3 [0.6] passes vs. 3.0 [1.1] passes [P < 0.001]; and 19.3 [8.0] vs. 22.7 [10.8] minutes [P = 0.008]). EUS-FNB alone cost on average 45 US dollars more than EUS-FNA + ROSE.

Conclusion EUS-FNB alone is non-inferior to EUS-FNA + ROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost.



Publication History

Received: 10 September 2020

Accepted after revision: 27 January 2021

Accepted Manuscript online:
27 January 2021

Article published online:
15 April 2021

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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