S C van Doorn1, M van der Vlugt1, Actm Depla2, C A Wientjes3, R C Mallant-Hent4, P D Siersema5, Kmaj Tytgat, H Tuynman1,2, S D Kuiken3, Gmp Houben2, Pcf Stokkers3, Lmg Moons5, Pmm Bossuyt6, P Fockens1, M W Mundt4, E Dekker1. 1. Departments of Gastroenterology & Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. 2. Departments of Gastroenterology & Hepatology, Slotervaartziekenhuis, Amsterdam, The Netherlands. 3. Departments of Gastroenterology & Hepatology, Sint Lucas Andreas Ziekenhuis, Amsterdam, The Netherlands. 4. Departments of Gastroenterology & Hepatology, Flevoziekenhuis, Almere, The Netherlands. 5. Departments of Gastroenterology & Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands. 6. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, Amsterdam, The Netherlands.
Abstract
BACKGROUND AND AIMS: Colonoscopy is the current reference standard for the detection of colorectal neoplasia, but nevertheless adenomas remain undetected. The Endocuff, an endoscopic cap with plastic projections, may improve colonic visualisation and adenoma detection. The aim of this study was to compare the mean number of adenomas per patient (MAP) and the adenoma detection rate (ADR) between Endocuff-assisted colonoscopy (EAC) and conventional colonoscopy (CC). METHODS: We performed a multicentre, randomised controlled trial in five hospitals and included fecal immonochemical test (FIT)-positive screening participants as well as symptomatic patients (>45 years). Consenting patients were randomised 1:1 to EAC or CC. All colonoscopies were performed by experienced colonoscopists (≥500 colonoscopies) who were trained in EAC. All colonoscopy quality indicators were prospectively recorded. FINDINGS: Of the 1063 included patients (52% male, median age 65 years), 530 were allocated to EAC and 533 to CC. More adenomas were detected with EAC, 722 vs 621, but the gain in MAP was not significant: on average 1.36 per patient in the EAC group versus 1.17 in the CC group (p=0.08). In a per-protocol analysis, the gain was 1.44 vs 1.19 (p=0.02), respectively. In the EAC group, 275 patients (52%) had one or more adenomas detected versus 278 in the CC group (52%; p=0.92). For advanced adenomas these numbers were 109 (21%) vs 117 (22%). The adjusted caecal intubation rate was lower with EAC (94% vs 99%; p<0.001), however when allowing crossover from EAC to CC, they were similar in both groups (98% vs 99%; p value=0.25). INTERPRETATION: Though more adenomas are detected with EAC, the routine use of Endocuff does not translate in a higher number of patients with one or more adenomas detected. Whether increased detection ultimately results in a lower rate of interval carcinomas is not yet known. TRIAL REGISTRATION NUMBER: http://www.trialregister.nl Dutch Trial Register: NTR3962. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
RCT Entities:
BACKGROUND AND AIMS: Colonoscopy is the current reference standard for the detection of colorectal neoplasia, but nevertheless adenomas remain undetected. The Endocuff, an endoscopic cap with plastic projections, may improve colonic visualisation and adenoma detection. The aim of this study was to compare the mean number of adenomas per patient (MAP) and the adenoma detection rate (ADR) between Endocuff-assisted colonoscopy (EAC) and conventional colonoscopy (CC). METHODS: We performed a multicentre, randomised controlled trial in five hospitals and included fecal immonochemical test (FIT)-positive screening participants as well as symptomatic patients (>45 years). Consenting patients were randomised 1:1 to EAC or CC. All colonoscopies were performed by experienced colonoscopists (≥500 colonoscopies) who were trained in EAC. All colonoscopy quality indicators were prospectively recorded. FINDINGS: Of the 1063 included patients (52% male, median age 65 years), 530 were allocated to EAC and 533 to CC. More adenomas were detected with EAC, 722 vs 621, but the gain in MAP was not significant: on average 1.36 per patient in the EAC group versus 1.17 in the CC group (p=0.08). In a per-protocol analysis, the gain was 1.44 vs 1.19 (p=0.02), respectively. In the EAC group, 275 patients (52%) had one or more adenomas detected versus 278 in the CC group (52%; p=0.92). For advanced adenomas these numbers were 109 (21%) vs 117 (22%). The adjusted caecal intubation rate was lower with EAC (94% vs 99%; p<0.001), however when allowing crossover from EAC to CC, they were similar in both groups (98% vs 99%; p value=0.25). INTERPRETATION: Though more adenomas are detected with EAC, the routine use of Endocuff does not translate in a higher number of patients with one or more adenomas detected. Whether increased detection ultimately results in a lower rate of interval carcinomas is not yet known. TRIAL REGISTRATION NUMBER: http://www.trialregister.nl Dutch Trial Register: NTR3962. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Authors: Martin Floer; Laura Tschaikowski; Michael Schepke; Radoslaw Kempinski; Katarzyna Neubauer; Elzbieta Poniewierka; Steffen Kunsch; Detlev Ameis; Hauke Sebastian Heinzow; Agneta Auer; Hartmut H Schmidt; Volker Ellenrieder; Tobias Meister Journal: United European Gastroenterol J Date: 2021-02-16 Impact factor: 4.623