Manuel Zorzi1, Cesare Hassan2, Jessica Battagello1, Giulio Antonelli2,3,4, Maurizio Pantalena5, Gianmarco Bulighin6, Saverio Alicante7, Tamara Meggiato8, Erik Rosa-Rizzotto9, Federico Iacopini4, Carmelo Luigiano10, Fabio Monica11, Arrigo Arrigoni12, Bastianello Germanà13, Flavio Valiante14, Beatrice Mallardi15, Carlo Senore16, Grazia Grazzini15, Paola Mantellini15. 1. Veneto Tumor Registry, Azienda Zero, Padova, Italy. 2. Gastroenterology Unit, Nuovo Regina Margherita Hospital, Rome, Italy. 3. Department of Translational and Precision Medicine, "Sapienza" University of Rome, Italy. 4. Gastroenterology and Digestive Endoscopy Unit, Ospedale dei Castelli (N.O.C.), ASL Roma 6, Ariccia, Rome, Italy. 5. Gastroenterology Unit, Cazzavillan Hospital, ULSS 8 Berica, Arzignano, Italy. 6. Gastroenterology and Digestive Endoscopy Unit, Fracastoro Hospital, ULSS 9 Scaligera, San Bonifacio, Italy. 7. Gastroenterology Department, ASST-Crema, Maggiore Hospital, Crema, Italy. 8. Department of Gastroenterology, Rovigo General Hospital, ULSS 5 Polesana, Rovigo, Italy. 9. Gastroenterology Unit, St. Anthony Hospital, Azienda Ospedale-Università, Padua, Italy. 10. Unit of Digestive Endoscopy, ASST Santi Paolo e Carlo, Milan, Italy. 11. Gastroenterology and Digestive Endoscopy Unit, Cattinara University Hospital, Trieste, Italy. 12. Gastroenterology Unit, University Hospital Città della Salute e della Scienza, Turin, Italy. 13. Gastroenterology and Digestive Endoscopy Unit, San Martino Hospital, ULSS 1 Dolomiti, Belluno, Italy. 14. Gastroenterology and Digestive Endoscopy Unit, Santa Maria del Prato Hospital, ULSS 1 Dolomiti, Feltre, Italy. 15. Screening Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO), Florence, Italy. 16. Epidemiology and Screening Unit - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy.
Abstract
BACKGROUND: The Endocuff Vision device (Arc Medical Design Ltd., Leeds, UK) has been shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicenter study assessed possible benefits and harms of using Endocuff Vision in a fecal immunochemical test (FIT)-based screening program. METHODS: Patients undergoing colonoscopy after a FIT-positive test were randomized 1:1 to undergo Endocuff-assisted colonoscopy or standard colonoscopy, stratified by sex, age, and screening history. Primary outcome was ADR. Secondary outcomes were ADR stratified by endoscopists' ADR, advanced ADR (AADR), adenomas per colonoscopy (APC), withdrawal time, and adverse events. RESULTS: 1866 patients were enrolled across 13 centers. After exclusions, 1813 (mean age 60.1 years; male 53.8 %) were randomized (908 Endocuff Vision, 905 standard colonoscopy). ADR was significantly higher in the Endocuff Vision arm (47.8 % vs. 40.8 %; relative risk [RR] 1.17, 95 % confidence interval [CI] 1.06-1.30), with no differences between arms regarding size or morphology. When stratifying for endoscopists' ADR, only low detectors (ADR < 33.3 %) showed a statistically significant ADR increase (Endocuff Vision 41.1 % [95 %CI 35.7-46.7] vs. standard colonoscopy 26.0 % [95 %CI 21.3-31.4]). AADR (24.8 % vs. 20.5 %, RR 1.21, 95 %CI 1.02-1.43) and APC (0.94 vs. 0.77; P = 0.001) were higher in the Endocuff Vision arm. Withdrawal time and adverse events were similar between arms. CONCLUSION: Endocuff Vision increased ADR in a FIT-based screening program by improving examination of the whole colonic mucosa. Utility was highest among endoscopists with a low ADR. Thieme. All rights reserved.
BACKGROUND: The Endocuff Vision device (Arc Medical Design Ltd., Leeds, UK) has been shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicenter study assessed possible benefits and harms of using Endocuff Vision in a fecal immunochemical test (FIT)-based screening program. METHODS: Patients undergoing colonoscopy after a FIT-positive test were randomized 1:1 to undergo Endocuff-assisted colonoscopy or standard colonoscopy, stratified by sex, age, and screening history. Primary outcome was ADR. Secondary outcomes were ADR stratified by endoscopists' ADR, advanced ADR (AADR), adenomas per colonoscopy (APC), withdrawal time, and adverse events. RESULTS: 1866 patients were enrolled across 13 centers. After exclusions, 1813 (mean age 60.1 years; male 53.8 %) were randomized (908 Endocuff Vision, 905 standard colonoscopy). ADR was significantly higher in the Endocuff Vision arm (47.8 % vs. 40.8 %; relative risk [RR] 1.17, 95 % confidence interval [CI] 1.06-1.30), with no differences between arms regarding size or morphology. When stratifying for endoscopists' ADR, only low detectors (ADR < 33.3 %) showed a statistically significant ADR increase (Endocuff Vision 41.1 % [95 %CI 35.7-46.7] vs. standard colonoscopy 26.0 % [95 %CI 21.3-31.4]). AADR (24.8 % vs. 20.5 %, RR 1.21, 95 %CI 1.02-1.43) and APC (0.94 vs. 0.77; P = 0.001) were higher in the Endocuff Vision arm. Withdrawal time and adverse events were similar between arms. CONCLUSION: Endocuff Vision increased ADR in a FIT-based screening program by improving examination of the whole colonic mucosa. Utility was highest among endoscopists with a low ADR. Thieme. All rights reserved.