Stefano Francesco Crinò1, Roberto Di Mitri2, Nam Q Nguyen3, Ilaria Tarantino4, Germana de Nucci5, Pierre H Deprez6, Silvia Carrara7, Masayuki Kitano8, Vanessa M Shami9, Gloria Fernández-Esparrach10, Jan-Werner Poley11, Francisco Baldaque-Silva12, Takao Itoi13, Erminia Manfrin14, Laura Bernardoni15, Armando Gabbrielli15, Elisabetta Conte2, Elettra Unti16, Jeevinesh Naidu3, Andrew Ruszkiewicz17, Michele Amata4, Rosa Liotta18, Gianpiero Manes5, Franca Di Nuovo19, Ivan Borbath6, Mina Komuta20, Laura Lamonaca7, Daoud Rahal21, Keiichi Hatamaru8, Masahiro Itonaga8, Gianenrico Rizzatti22, Guido Costamagna23, Frediano Inzani24, Mariangela Curatolo24, Daniel S Strand9, Andrew Y Wang9, Àngels Ginès10, Oriol Sendino10, Marianna Signoretti25, Lydi M J W van Driel11, Karoly Dolapcsiev26, Yukitoshi Matsunami13, Schalk van der Merwe27, Hannah van Malenstein27, Francesca Locatelli28, Loredana Correale15, Aldo Scarpa29, Alberto Larghi23. 1. Digestive Endoscopy Unit, The Pancreas Institute, G.B. Rossi University Hospital, Verona, Italy. Electronic address: stefanofrancesco.crino@aovr.veneto.it. 2. Gastroenterology and Endoscopy Unit, ARNAS Civico Di Cristina Benfratelli Hospital, Palermo, Italy. 3. Department of Gastroenterology, Royal Adelaide Hospital, South Australia. 4. Endoscopy Service, Department of Diagnostic and Therapeutic Services, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS-ISMETT), Palermo, Italy. 5. Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy. 6. Department of Gastroenterology and Hepatology, Cliniques universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles, Belgium. 7. Department of Gastroenterology, Endoscopic Unit, Humanitas Clinical and Research Center- IRCCS, Rozzano (MI), Italy. 8. Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan. 9. Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, Virginia. 10. Endoscopy Unit, Department of Gastroenterology, Hospital Clínic Barcelona, IDIBAPS, CIBEREHD, University of Barcelona, Barcelona, Spain. 11. Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands. 12. Department of Upper GI Diseases, Unit of Gastrointestinal Endoscopy, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden. 13. Department of Gastroenterology and Hepatology, Tokyo Medical University, Shinjuku, Tokyo, Japan. 14. Department of Diagnostics and Public Health, Section of Pathology, G.B. Rossi University Hospital, Verona, Italy. 15. Digestive Endoscopy Unit, The Pancreas Institute, G.B. Rossi University Hospital, Verona, Italy. 16. Pathology Unit, ARNAS Civico Di Cristina Benfratelli Hospital, Palermo, Italy. 17. SA Pathology Adelaide, Royal Adelaide Hospital, South Australia. 18. Pathology Service, Department of Diagnostic and Therapeutic Services, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS - ISMETT), Palermo, Italy. 19. Pathology Unit, ASST Rhodense, Garbagnate Milanese (MI), Italy. 20. Department of Pathology, School of Medicine, Keio University, Tokyo, Japan; Department of Pathology, Cliniques universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles, Belgium. 21. Department of Pathology, Humanitas Clinical and Research Center-IRCCS, Rozzano (MI), Italy. 22. Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. 23. Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy; CERTT, Center for Endoscopic Research Therapeutics and Training, Catholic University, Rome, Italy. 24. Pathology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. 25. Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands; Digestive and Liver Disease Unit, Sant'Andrea Hospital, Sapienza University, Rome, Italy. 26. Department of Pathology, Karolinska University Laboratory, Karolinska University Hospital, Stockholm, Sweden. 27. Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Belgium. 28. Unit of Epidemiology and Medical Statistics, Department of Diagnostics and Public Health, G.B. Rossi University Hospital, Verona, Italy. 29. Department of Diagnostics and Public Health, Section of Pathology, G.B. Rossi University Hospital, Verona, Italy; ARC-Net Research Centre, University of Verona, G.B. Rossi University Hospital, Verona, Italy.
Abstract
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.).
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.).
Authors: Labrinus van Manen; Iris Schmidt; Akin Inderson; Ruben D Houvast; Jurjen J Boonstra; Jouke Dijkstra; Jeanin E van Hooft; Wouter B Nagengast; Dominic J Robinson; Alexander L Vahrmeijer; J Sven D Mieog Journal: Int J Med Sci Date: 2022-01-01 Impact factor: 3.738
Authors: Lenka N C Boyd; Mahsoem Ali; Laura Kam; Jisce R Puik; Stephanie M Fraga Rodrigues; Eline S Zwart; Freek Daams; Barbara M Zonderhuis; Laura L Meijer; Tessa Y S Le Large; Elisa Giovannetti; Hanneke W M van Laarhoven; Geert Kazemier Journal: Cancers (Basel) Date: 2022-01-11 Impact factor: 6.639