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

Michiel H. J. Maas; Timo Rath; Cristiano Spada; Elsa Soons; Nauzer Forbes; Sergey Kashin; Paola Cesaro; Axel Eickhoff; Geoffroy Vanbiervliet; Daniele Salvi; Paul J. Belletrutti; Peter D. Siersema; for the Discovery study team

doi:10.1055/a-2328-2844

Endoscopy, Table of Contents

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

¹Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands

,

Timo Rath

²Department of Medicine I, Division of Gastroenterology, Universitätsklinikum Erlangen, Erlangen, Germany

,

Cristiano Spada

³Department of Gastroenterology and Endoscopy, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy

⁴Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

,

Elsa Soons

¹Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands

,

Nauzer Forbes

⁵Department of Medicine, University of Calgary, Calgary, Canada

,

Sergey Kashin

⁶Department of Endoscopy, Yaroslavl Regional Cancer Hospital, Yaroslavl, Russia

,

Paola Cesaro

³Department of Gastroenterology and Endoscopy, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy

,

Axel Eickhoff

⁷Gastroenterology, Diabetology, Infectiology, Klinikum Hanau, Hanau, Germany

,

Geoffroy Vanbiervliet

⁸Pôle digestif, Hôpital L’Archet, Nice, France

,

Daniele Salvi

³Department of Gastroenterology and Endoscopy, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy

⁴Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

,

Paul J. Belletrutti

⁵Department of Medicine, University of Calgary, Calgary, Canada

,

Peter D. Siersema

¹Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands

⁹ErasmusMC – University Medical Center, Rotterdam, the Netherlands

,

for the Discovery study team

› Author Affiliations

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.

Full Text

References

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Supplementary Material

Supplementary material