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.

Published on Jun 8, 2021in Gastroenterology17.373
· DOI :10.1053/J.GASTRO.2021.06.005
Stefano Francesco Crinò14
Estimated H-index: 14
Roberto Di Mitri11
Estimated H-index: 11
+ 45 AuthorsGloria Fernández-Esparrach33
Estimated H-index: 33
(University of Barcelona)
ABSTRACT null null Background and aims null Benefit of rapid on-site evaluation (ROSE) on 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. null null null Methods null Non-inferiority study (non-inferiority margin 5%) conducted at 14 centers in eight 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. Primary endpoint was diagnostic accuracy. Secondary endpoints included safety, tissue core procurement, specimen quality, and sampling procedural time. null null null Results null Eight hundred patients were randomized over an 18-month period, and 771 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=0.396). Non-inferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (two-sided 90% CI: -1.1% to 3.1%, pnon-inferiority null null null Conclusion null EUS-FNB demonstrated high diagnostic accuracy to evaluate SPLs independently on execution of ROSE. When new generation FNB needles are used, ROSE should not be routinely recommended. null ClinicalTrial.gov , number NCT03322592.
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