David Karsenti 1 , Gaelle Tharsis 2 , Bastien Perrot 3 , Philippe Cattan 2 , Gilles Tordjman 2 , Franck Venezia 2 , Elie Zrihen 2 , Dominique Gillot 2 , Agnes Gillet 2 , Charles Hagege 2 , Joelle Samama 2 , Isabelle Etienney 2 , Jean-Philippe Lab 4 , Bernard Guigui 4 , Jacqueline Zago 5 , Bouchra Benkessou 2 , Pascal Burtin 6 , Maryan Cavicchi 2 Show Affiliations »
Abstract
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OBJECTIVE: Endocuff Vision (ECV ) is the second generation of a device designed to improve polyp detection. The aim of this study was to evaluate its impact on adenoma detection rate (ADR ) in routine colonoscopy. DESIGN: This cluster-randomised crossover trial compared Endocuff-assisted (ECV+) with standard (ECV-) colonoscopy . Two teams of 11 endoscopists each with prior ECV experience, balanced in terms of basal ADR, gender and case volume were compared. In randomised fashion, the teams started with ECV+ or ECV - and switched group after inclusion of half of the cases. The main outcome criterion was ADR difference between ECV+ and ECV -. Subgroup analysis was done for physicians with low and high ADR (< or ≥ 25%). RESULTS: During two periods of 20 and 21 weeks, respectively, the 22 endoscopists included 2058 patients (1032 ECV - vs 1026 ECV +, both groups being comparable). Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV - first), but mostly in adenomas <1 cm. In the physician subgroup analysis, only high detectors showed a significant ADR increase (from 31% to 41%, p<0.001), while the increase in the low detectors was not significant (from 24% to 30%, p=0.11). ECV had a positive impact in all colonic locations, except for the rectum. No ECV - related complication was reported. CONCLUSION: We observed a significant ADR difference of approximately 10% by the use of ECV . By subgroup analysis, this increase was significant only in physicians classified as high detectors. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03344055). © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.
RCT Entities: Population
Interventions
Outcomes
OBJECTIVE: Endocuff Vision (ECV) is the second generation of a device designed to improve polyp detection. The aim of this study was to evaluate its impact on adenoma detection rate (ADR) in routine colonoscopy. DESIGN: This cluster-randomised crossover trial compared Endocuff-assisted (ECV+) with standard (ECV-) colonoscopy. Two teams of 11 endoscopists each with prior ECV experience, balanced in terms of basal ADR, gender and case volume were compared. In randomised fashion, the teams started with ECV+ or ECV- and switched group after inclusion of half of the cases. The main outcome criterion was ADR difference between ECV+ and ECV-. Subgroup analysis was done for physicians with low and high ADR (< or ≥ 25%). RESULTS: During two periods of 20 and 21 weeks, respectively, the 22 endoscopists included 2058 patients (1032 ECV- vs 1026 ECV+, both groups being comparable). Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV- first), but mostly in adenomas <1 cm. In the physician subgroup analysis, only high detectors showed a significant ADR increase (from 31% to 41%, p<0.001), while the increase in the low detectors was not significant (from 24% to 30%, p=0.11). ECV had a positive impact in all colonic locations, except for the rectum. No ECV- related complication was reported. CONCLUSION: We observed a significant ADR difference of approximately 10% by the use of ECV. By subgroup analysis, this increase was significant only in physicians classified as high detectors. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03344055). © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.
Entities: Disease
Species
Keywords:
colonoscopy; colorectal adenomas
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Year: 2020
PMID： 32209605 DOI： 10.1136/gutjnl-2019-319565
Source DB: PubMed Journal: Gut ISSN： 0017-5749 Impact factor: 23.059