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, Avijit Chatterjee, Robert Berger, Yonca Kanber, Jonathan Wyse, Eric Lam, Ian Gan, Manon Auger, Sana Kenshil, Jennifer Telford, Fergal Donnellan, James Quinlan, Gregory Lutzak, Fatma Alshamsi, Josee Parent, Kevin Waschke, Adel Alghamdi, Jeffrey Barkun, Peter Metrakos, Prosanto Chaudhury, Myriam Martel, Alastair Dorreen, Kristen Candido, Corey Miller, Viviane Adam, Alan Barkun, George Zogopoulos, Clarence Wong, Yen-I Chen, Avijit Chatterjee, Robert Berger, Yonca Kanber, Jonathan Wyse, Eric Lam, Ian Gan, Manon Auger, Sana Kenshil, Jennifer Telford, Fergal Donnellan, James Quinlan, Gregory Lutzak, Fatma Alshamsi, Josee Parent, Kevin Waschke, Adel Alghamdi, Jeffrey Barkun, Peter Metrakos, Prosanto Chaudhury, Myriam Martel, Alastair Dorreen, Kristen Candido, Corey Miller, Viviane Adam, Alan Barkun, George Zogopoulos, Clarence Wong
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.
Trial registration: ClinicalTrials.gov NCT03435588.
Conflict of interest statement
Yen-I Chen, Avijit Chatterjee, Ian Gan, and Fergal Donnellan are consultants for Boston Scientific. Alan Barkun is a consultant for Pendopharm Inc., Boston Scientific Inc., Olympus Inc., Cook Inc., and ATGen Inc. Clarence Wong is a consultant for Boston Scientific and Medtronic Medical. The remaining authors declare that they have no conflict of interest.
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Source: PubMed