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CC BY 4.0 · Endoscopy 2024; 56(11): 843-850
DOI: 10.1055/a-2328-2844
Original article

A computer-aided detection system in the everyday setting of diagnostic, screening, and surveillance colonoscopy: an international, randomized trial

Michiel H. J. Maas 
1   Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands
,
Timo Rath
2   Department of Medicine I, Division of Gastroenterology, Universitätsklinikum Erlangen, Erlangen, Germany
,
Cristiano Spada
3   Department of Gastroenterology and Endoscopy, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
4   Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
,
Elsa Soons
1   Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands
,
Nauzer Forbes 
5   Department of Medicine, University of Calgary, Calgary, Canada
,
Sergey Kashin
6   Department of Endoscopy, Yaroslavl Regional Cancer Hospital, Yaroslavl, Russia
,
Paola Cesaro
3   Department of Gastroenterology and Endoscopy, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
,
Axel Eickhoff
7   Gastroenterology, Diabetology, Infectiology, Klinikum Hanau, Hanau, Germany
,
Geoffroy Vanbiervliet 
8   Pôle digestif, Hôpital L’Archet, Nice, France
,
Daniele Salvi
3   Department of Gastroenterology and Endoscopy, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
4   Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
,
Paul J. Belletrutti
5   Department of Medicine, University of Calgary, Calgary, Canada
,
Peter D. Siersema
1   Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands
9   ErasmusMC – University Medical Center, Rotterdam, the Netherlands
,
for the Discovery study team › Author AffiliationsPENTAX Medical

Trial Registration: Uniform Trial Number (http://www.who.int/ictrp/unambiguous_identification/en/) Registration number (trial ID): NL9135 Type of study: Prospective, Randomized, Multicenter study
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Referred to by:

Author commentary on Michiel H. J. Maas et al.Endoscopy 2024; 56(11): v26-v26
DOI: 10.1055/a-2343-1586

Referred to by:

Will computer-aided detection of polyps decrease colorectal cancer incidence and mortality?Endoscopy 2024; 56(11): 851-852
DOI: 10.1055/a-2371-1556

Abstract

Background Computer-aided detection (CADe) has been developed to improve detection during colonoscopy. After initial reports of high efficacy, there has been an increasing recognition of variability in the effectiveness of CADe systems. The aim of this study was to evaluate a CADe system in a varied colonoscopy population.

Methods A multicenter, randomized trial was conducted at seven hospitals (both university and non-university) in Europe and Canada. Participants referred for diagnostic, non-immunochemical fecal occult blood test (iFOBT) screening, or surveillance colonoscopy were randomized (1:1) to undergo CADe-assisted or conventional colonoscopy by experienced endoscopists. Participants with insufficient bowel preparation were excluded from the analysis. The primary outcome was adenoma detection rate (ADR). Secondary outcomes included adenomas per colonoscopy (APC) and sessile serrated lesions (SSLs) per colonoscopy.

Results 581 participants were enrolled, of whom 497 were included in the final analysis: 250 in the CADe arm and 247 in the conventional colonoscopy arm. The indication was surveillance in 202/497 colonoscopies (40.6 %), diagnostic in 199/497 (40.0 %), and non-iFOBT screening in 96/497 (19.3 %). Overall, ADR (38.4 % vs. 37.7 %; P = 0.43) and APC (0.66 vs. 0.66; P = 0.97) were similar between CADe and conventional colonoscopy. SSLs per colonoscopy was increased (0.30 vs. 0.19; P = 0.049) in the CADe arm vs. the conventional colonoscopy arm.

Conclusions In this study conducted by experienced endoscopists, CADe did not result in a statistically significant increase in ADR. However, the ADR of our control group substantially surpassed our sample size assumptions, increasing the risk of an underpowered trial.

Supplementary Material



Publication History

Received: 10 February 2024

Accepted after revision: 15 May 2024

Accepted Manuscript online:
15 May 2024

Article published online:
27 June 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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