• Priscilla A van Riet, Alberto Larghi, Fabia Attili, Guido Rindi, Nam Quoc Nguyen, Andrew Ruszkiewicz, Masayuki Kitano, Takaaki Chikugo, Harry Aslanian, James Farrell, Marie Robert, Adebowale Adeniran, Schalk Van Der Merwe, Tania Roskams, Kenneth Chang, Fritz Lin, John G Lee, Paolo Giorgio Arcidiacono, Mariachiara Petrone, Claudio Doglioni, Julio Iglesias-Garcia, Ihab Abdulkader, Marc Giovannini, Erwan Bories, Flora Poizat, Erwin Santo, Erez Scapa, Silvia Marmor, Juan Carlos Bucobo, Jonathan M Buscaglia, Alan Heimann, Maoxin Wu, Francisco Baldaque-Silva, Carlos Fernández Moro, Nicole S Erler, Katharina Biermann, Jan-Werner Poley, Djuna L Cahen, and Marco J Bruno.
• Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
• Gastrointest. Endosc. 2019 Feb 1; 89 (2): 329-339.

Background And AimsSeveral studies have compared EUS-guided FNA with fine-needle biopsy (FNB), but none have proven superiority. We performed a multicenter randomized controlled trial to compare the performance of a commonly used 25-gauge FNA needle with a newly designed 20-gauge FNB needle.MethodsConsecutive patients with a solid lesion were randomized in this international multicenter study between a 25-gauge FNA (EchoTip Ultra) or a 20-gauge FNB needle (ProCore). The primary endpoint was diagnostic accuracy for malignancy and the Bethesda classification (non-diagnostic, benign, atypical, malignant). Technical success, safety, and sample quality were also assessed. Multivariable and supplementary analyses were performed to adjust for confounders.ResultsA total of 608 patients were allocated to FNA (n = 306) or FNB (n = 302); 312 pancreatic lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Technical success rate was 100% for the 25-gauge FNA and 99% for the 20-gauge FNB needle (P = .043), with no differences in adverse events. The 20-gauge FNB needle outperformed 25-gauge FNA in terms of histologic yield (77% vs 44%, P < .001), accuracy for malignancy (87% vs 78%, P = .002) and Bethesda classification (82% vs 72%, P = .002). This was robust when corrected for indication, lesion size, number of passes, and presence of an on-site pathologist (odds ratio, 3.53; 95% confidence interval, 1.55-8.56; P = .004), and did not differ among centers (P = .836).ConclusionThe 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histologic yield and diagnostic accuracy. This benefit was irrespective of the indication and was consistent among participating centers, supporting the general applicability of our findings. (Clinical trial registration number: NCT02167074.).Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

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