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.

Crinò, Stefano Francesco Di Mitri, Roberto Nguyen, Nam Q Tarantino, Ilaria de Nucci, Germana Deprez, Pierre Henri [UCL] Carrara, Silvia Kitano, Masayuki Shami, Vanessa M Fernández-Esparrach, Gloria Poley, Jan-Werner Baldaque-Silva, Francisco Itoi, Takao Manfrin, Erminia Bernardoni, Laura Gabbrielli, Armando Conte, Elisabetta Unti, Elettra Naidu, Jeevinesh Ruszkiewicz, Andrew Amata, Michele Liotta, Rosa Manes, Gianpiero Di Nuovo, Franca Borbath, Ivan [UCL] Komuta, Mina [UCL] Lamonaca, Laura Rahal, Daoud Hatamaru, Keiichi Itonaga, Masahiro Rizzatti, Gianenrico Costamagna, Guido Inzani, Frediano Curatolo, Mariangela Strand, Daniel S Wang, Andrew Y Ginès, Àngels Sendino, Oriol Signoretti, Marianna van Driel, Lydi M J W Dolapcsiev, Karoly Matsunami, Yukitoshi van der Merwe, Schalk van Malenstein, Hannah Locatelli, Francesca Correale, Loredana Scarpa, Aldo Larghi, Alberto et al.[show all]

(eng) 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.).