EUS-FNB WITH VERSUS WITHOUT ROSE: INTERIM ANALYSIS OF AN INTERNATIONAL RANDOMIZED NON-INFERIORITY STUDY

SF Crinò; RD Mitri; NQ Nguyen; GD Nucci; P Deprez; I Tarantino; S Carrara; M Kitano; JW Poley; V Shami; A Ginés; F Baldaque-Silva; T Itoi; J Iglesias-Garcia; A Scarpa; A Gabbrielli; E Manfrin; A Larghi

doi:10.1055/s-0040-1704040

Endoscopy, Inhaltsverzeichnis

Endoscopy 2020; 52(S 01): S10-S11
DOI: 10.1055/s-0040-1704040

ESGE Days 2020 oral presentations

Thursday, April 23, 2020 16:30 – 18:00 President’s opening session 3 Auditorium

EUS-FNB WITH VERSUS WITHOUT ROSE: INTERIM ANALYSIS OF AN INTERNATIONAL RANDOMIZED NON-INFERIORITY STUDY

Authors

SF Crinò

¹University of Verona, Digestive Endoscopy Unit, Verona, Italy
RD Mitri

²Arnas Civico Di Cristina Benfratelli Hospital, Gastroenterology and Endoscopy Unit, Department of Gastroenterology and Hepatology, Palermo, Italy
NQ Nguyen

³Royal Adelaide Hospital, Adelaide, Australia
GD Nucci

⁴Rho and Garbagnate Milanese Hospital, ASST Rhodense, Department of Gastroenterology and Hepatology, Milano, Italy
P Deprez

⁵Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Department of Gastroenterology and Hepatology, Bruxelles, Belgium
I Tarantino

⁶IRCCS-ISMETT (Mediterranean Institute for Transplantation and Highly Specialized Therapies), Endoscopy Service, Department of Diagnostic and Therapeutic Services, Palermo, Italy
S Carrara

⁷Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Milano, Italy
M Kitano

⁸Kindai University School of Medicine, Department of Gastroenterology and Hepatology,Osakasayama, Japan
JW Poley

⁹University Medical Centre, Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, Netherlands
V Shami

¹⁰University of Virginia Health System, Division of Gastroenterology and Hepatology, Charlottesville, United States of America
A Ginés

¹¹Hospital Clínic Barcelona, IDIBAPS, University of Barcelona, Gastrointestinal Department, Barcellona, Spain
F Baldaque-Silva

¹²Unit of Gastrointestinal Endoscopy, Karolinska University Hospital and Karolinska Institute, Department of Upper GI Diseases, Stockholm, Sweden
T Itoi

¹³Tokyo Medical University, Department of Gastroenterology and Hepatology, Tokyo, Japan
J Iglesias-Garcia

¹⁴University Hospital of Santiago de Compostela, Department of Gastroenterology and Hepatology, Santiago de Compostela, Spain
A Scarpa

¹⁵G.B. Rossi University Hospital, Department of Diagnostics and Public Health, Verona, Italy
A Gabbrielli

¹University of Verona, Digestive Endoscopy Unit, Verona, Italy
E Manfrin

¹⁵G.B. Rossi University Hospital, Department of Diagnostics and Public Health, Verona, Italy
A Larghi

¹⁶Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Centre for Endoscopic Research Therapeutics and Training (CERTT), Digestive Endoscopy Unit, Roma, Italy

Abstract

Volltext

Aims To assess if the need of rapid on-site evaluation (ROSE) during EUS-FNB of solid pancreatic lesions (SPLs) can be overcome by the high diagnostic accuracy of new devices.

Methods Randomized non-inferiority study comparing EUS-FNB+ROSE vs. EUS-FNB alone in patients with SPLs. The procedures were done using one of the available FNB needles (SharkCore22G, Acquire22G, ProCore20G) with 3 needle passes performed and the touch imprint cytology technique (TIC) utilized for ROSE. In the ROSE arm when adequacy with TIC was reached, additional passes up to an overall of 3 were performed for histological evaluation. Samples suspicious for malignancy were considered false negative when final diagnosis of malignancy was ascertained. Diagnostic accuracy was measured against definitive surgical pathology or after a clinical course of at least six months congruent with the diagnosis. Secondary endpoints included: safety, presence of tissue core, quality of specimens and time of the sampling procedure.

Results We completed the enrollment of the whole 800 patients needed to finish the study. At present, 327 patients have completed the follow-up (193 males, mean age 66.6±11). Patients’ and lesions’ characteristics in the two arms were similar. Comparable diagnostic accuracies were obtained with or without ROSE [90.3% (95% CI 84.7-94.4) vs 91.3% (95% CI 85.9-95.2), respectively]. Safety, presence of tissue core, and sample quality of histological specimens were similar in the two groups. The mean time of the sampling procedure was significantly longer in the ROSE group (16.1±7.2 vs 11.5±6.0 minutes, p< 0.0001). Significantly higher rate of tissue core procurement was obtained using the end-cutting needles than the side-fenestrated needle (48.9% vs 75% vs 69.7% using Procore 20G, SharkCore 22G, and Acquire 22G, respectively, p< 0.0001).

Conclusions Our preliminary results show that ROSE is not associated with better accuracy of EUS-FNB alone and its utilization increases the duration of the procedure.