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Original research
Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial
  1. David Karsenti1,
  2. Gaelle Tharsis1,
  3. Bastien Perrot2,
  4. Philippe Cattan1,
  5. Gilles Tordjman1,
  6. Franck Venezia1,
  7. Elie Zrihen1,
  8. Dominique Gillot1,
  9. Agnes Gillet1,
  10. Charles Hagege1,
  11. Joelle Samama1,
  12. Isabelle Etienney1,
  13. Jean-Philippe Lab3,
  14. Bernard Guigui3,
  15. Jacqueline Zago4,
  16. Bouchra Benkessou1,
  17. Pascal Burtin5,
  18. Maryan Cavicchi1
  1. 1Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France
  2. 2Methodology Unit, UMR INSERM 1246 SPHERE, Université de Nantes, Université de Tours, Institut de Recherche en Santé (IRS2), Universite de Nantes, Nantes, Pays de la Loire, France
  3. 3Private Pathology Institute, Rue de Wattignies, Paris, France
  4. 4Private Pathology Institute, Rue du Colisée, Paris, France
  5. 5Digestive Oncology, Insitut Gustave Roussy, Villejuif, Île-de-France, France
  1. Correspondence to Dr David Karsenti, Endoscopy Unit, Clinique Paris-Bercy, Charenton-le-Pont 75006, France; karsenti{at}club-internet.fr

Abstract

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).

  • colorectal adenomas
  • colonoscopy
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Footnotes

  • Collaborators Karine Nahon-Uzan; Christine Grateau; Mireille Petit; Olivier Pecriaux; Annie Harboun; Jean-David Zeitoun; Franck Bumsel; Anne-Marie Roycourt; Ariane Chryssostalis; Hugues Demont; Cindy Cordier; Adelaïde Hazoume; Stéphanie Pereira; Emilie Ricq; Anne Tselikas. From the Pôle Digestif Paris-Bercy, clinique Paris-Bercy, Endoscopy Unit, Charenton-le-Pont, FR.

  • Funding This study was funded by Société Française d'Endoscopie Digestive (SFED 2016).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Ethics approval The protocol was approved by the Ouest-VI ethics committee of University Hospital – Brest, France, (#CPP Ouest 6 – CPP 995 DM2) and the French national drug safety agency (ANSM; #2017-A00549-44).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.

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