Trial protocol for COLO-DETECT: A randomized controlled trial of lesion detection comparing colonoscopy assisted by the GI Genius™ artificial intelligence endoscopy module with standard colonoscopy

Alexander Seager, Linda Sharp, James S Hampton, Laura J Neilson, Tom J W Lee, Andrew Brand, Rachel Evans, Luke Vale, John Whelpton, Colin J Rees, Alexander Seager, Linda Sharp, James S Hampton, Laura J Neilson, Tom J W Lee, Andrew Brand, Rachel Evans, Luke Vale, John Whelpton, Colin J Rees

Abstract

Aim: Colorectal cancer is the second commonest cause of cancer death worldwide. Colonoscopy plays a key role in the control of colorectal cancer and, in that regard, maximizing detection (and removal) of pre-cancerous adenomas at colonoscopy is imperative. GI Genius™ (Medtronic Ltd) is a computer-aided detection system that integrates with existing endoscopy systems and improves adenoma detection during colonoscopy. COLO-DETECT aims to assess the clinical and cost effectiveness of GI Genius™ in UK routine colonoscopy practice.

Methods and analysis: Participants will be recruited from patients attending for colonoscopy at National Health Service sites in England, for clinical symptoms, surveillance or within the national Bowel Cancer Screening Programme. Randomization will involve a 1:1 allocation ratio (GI Genius™-assisted colonoscopy:standard colonoscopy) and will be stratified by age category (<60 years, 60-<74 years, ≥74 years), sex, hospital site and indication for colonoscopy. Demographic data, procedural data, histology and post-procedure patient experience and quality of life will be recorded. COLO-DETECT is designed and powered to detect clinically meaningful differences in mean adenomas per procedure and adenoma detection rate between GI Genius™-assisted colonoscopy and standard colonoscopy groups. The study will close when 1828 participants have had a complete colonoscopy. An economic evaluation will be conducted from the perspective of the National Health Service. A patient and public representative is contributing to all stages of the trial. Registered at ClinicalTrials.gov (NCT04723758) and ISRCTN (10451355). WHAT WILL THIS TRIAL ADD TO THE LITERATURE?: COLO-DETECT will be the first multi-centre randomized controlled trial evaluating GI Genius™ in real world colonoscopy practice and will, uniquely, evaluate both clinical and cost effectiveness.

Keywords: adenoma; artificial intelligence; colonoscopy; colorectal cancer; computer-aided detection; economic evaluation.

Conflict of interest statement

Colin J Rees has received grant funding from ARC Medical, Norgine, Medtronic, 3D Matrix Solutions and Olympus Medical. He was an expert witness for ARC Medical. The remaining authors, and all study site PIs, declare no competing interests.

© 2022 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.

Figures

FIGURE 1
FIGURE 1
The GI Genius™ intelligent endoscopy module (©Medtronic Ltd)
FIGURE 2
FIGURE 2
A colonic polyp highlighted within a green bounding box by GI Genius™ (©Medtronic Ltd)
FIGURE 3
FIGURE 3
COLO‐DETECT participant flowchart

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