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Endoscopy 2022; 54(02): 138-147
DOI: 10.1055/a-1379-6868
Original article

Adenoma detection by Endocuff-assisted versus standard colonoscopy in an organized screening program: the “ItaVision” randomized controlled trial

Manuel Zorzi
1   Veneto Tumor Registry, Azienda Zero, Padova, Italy
,
Cesare Hassan
2   Gastroenterology Unit, Nuovo Regina Margherita Hospital, Rome, Italy
,
Jessica Battagello
1   Veneto Tumor Registry, Azienda Zero, Padova, Italy
,
Giulio Antonelli
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
,
Maurizio Pantalena
5   Gastroenterology Unit, Cazzavillan Hospital, ULSS 8 Berica, Arzignano, Italy
,
Gianmarco Bulighin
6   Gastroenterology and Digestive Endoscopy Unit, Fracastoro Hospital, ULSS 9 Scaligera, San Bonifacio, Italy
,
Saverio Alicante
7   Gastroenterology Department, ASST-Crema, Maggiore Hospital, Crema, Italy
,
Tamara Meggiato
8   Department of Gastroenterology, Rovigo General Hospital, ULSS 5 Polesana, Rovigo, Italy
,
Erik Rosa-Rizzotto
9   Gastroenterology Unit, St. Anthony Hospital, Azienda Ospedale-Università, Padua, Italy
,
Federico Iacopini
4   Gastroenterology and Digestive Endoscopy Unit, Ospedale dei Castelli (N.O.C.), ASL Roma 6, Ariccia, Rome, Italy
,
Carmelo Luigiano
10   Unit of Digestive Endoscopy, ASST Santi Paolo e Carlo, Milan, Italy
,
Fabio Monica 
11   Gastroenterology and Digestive Endoscopy Unit, Cattinara University Hospital, Trieste, Italy
,
Arrigo Arrigoni
12   Gastroenterology Unit, University Hospital Città della Salute e della Scienza, Turin, Italy
,
Bastianello Germanà
13   Gastroenterology and Digestive Endoscopy Unit, San Martino Hospital, ULSS 1 Dolomiti, Belluno, Italy
,
Flavio Valiante
14   Gastroenterology and Digestive Endoscopy Unit, Santa Maria del Prato Hospital, ULSS 1 Dolomiti, Feltre, Italy
,
Beatrice Mallardi
15   Screening Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO), Florence, Italy
,
Carlo Senore
16   Epidemiology and Screening Unit – CPO, University Hospital Città della Salute e della Scienza, Turin, Italy
,
Grazia Grazzini   *
15   Screening Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO), Florence, Italy
,
Paola Mantellini
15   Screening Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO), Florence, Italy
,
and the ItaVision Working Group
› Author AffiliationsSupported by: Norgine Italia Srl N/A

Trial Registration: ClinicalTrials.gov Registration number (trial ID): NCT03612674 Type of study: Prospective, Randomized, Multicentric trial
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Author commentary on Manuel Zorzi et al.Endoscopy 2022; 54(02): v5-v5
DOI: 10.1055/a-1431-1265

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.

* Deceased


Table s1–s3



Publication History

Received: 18 September 2020

Accepted: 01 February 2021

Accepted Manuscript online:
01 February 2021

Article published online:
08 April 2021

© 2021. Thieme. All rights reserved.

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