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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Endoscopic Ultrasound–guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial
Gastroenterology, Volume 161, No. 3, Year 2021
Notification
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Description
Background and Aims: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound–guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. Methods: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. Results: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, –1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). Conclusions: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.) © 2021 AGA Institute
Authors & Co-Authors
Nguyen, Nam Quoc
Australia, Adelaide
Royal Adelaide Hospital
TARANTINO, I.
Italy, Palermo
Istituto Mediterraneo Per I Trapianti e Terapie ad Alta Specializzazione
Carrara, Silvia
Italy, Rozzano
Humanitas Research Hospital
Kitano, Masayuki
Japan, Wakayama
Wakayama Medical University
Fernández-Esparrach, Gloria
Spain, Barcelona
Institut D'investigacions Biomèdiques August pi I Sunyer - Idibaps
Poley, Jan Werner
Netherlands, Rotterdam
Erasmus Mc
Itoi, Takao
Japan, Tokyo
Tokyo Medical University
Ruszkiewicz, Andrew R.
Australia, Adelaide
Royal Adelaide Hospital
Liotta, Rosa
Italy, Palermo
Istituto Mediterraneo Per I Trapianti e Terapie ad Alta Specializzazione
Borbath, Ivan
Belgium, Louvain-la-neuve
Université Catholique de Louvain
Lamonaca, Laura
Italy, Rozzano
Humanitas Research Hospital
Costamagna, Guido
Italy, Rome
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Italy, Rome
Università Cattolica Del Sacro Cuore, Campus Di Roma
van der Merwe, Schalk Willem
Belgium, Leuven
Ku Leuven
Correale, Loredana
Unknown Affiliation
Scarpa, Aldo
Italy, Verona
Università Degli Studi Di Verona
Larghi, Alberto
Italy, Rome
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Italy, Rome
Università Cattolica Del Sacro Cuore, Campus Di Roma
Statistics
Citations: 88
Authors: 16
Affiliations: 18
Identifiers
Doi:
10.1053/j.gastro.2021.06.005
ISSN:
00165085