aceThe VISION-AI Trial: protocol for a pragmatic randomized controlled non-inferiority trial comparing artificial intelligence-guided colonoscopy to pancolonic chromoendoscopy for neoplasia detection in adults with colorectal inflammatory bowel disease
Current guidelines recommend pancolonic chromoendoscopy (pCE) over white light endoscopy (WLE) alone for colorectal neoplasia (CRN) detection in individuals with inflammatory bowel diseases (IBD). However, these techniques are poorly adopted due to technical and logistical limitations. Artificial intelligence-based computer-aided detection (CADe) is a promising new technology integrated into modern endoscopy platforms that has been shown to increase CRN detection in the non-IBD population. We aim to compare CADe…
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On July 17, 2026, BMC Gastroenterology published the VISION-AI protocol for a pragmatic multicenter non-inferiority randomized trial comparing artificial intelligence-based computer-aided detection guided colonoscopy to pancolonic chromoendoscopy for visible colorectal neoplasia detection in adults with longstanding inflammatory bowel disease. The design targets 752 participants with a 15% anticipated neoplasia rate and 7.5% non-inferiority margin, and reports that enrollment started in April 2026 with 19 participants recruited by June 8, 2026.
The trial matters because individuals with inflammatory bowel disease face elevated colorectal cancer risk and guideline-recommended chromoendoscopy is poorly adopted, creating a need for more implementable detection strategies. Whether AI trained largely on non-IBD lesions can achieve non-inferior detection in inflamed and scarred mucosa remains unproven, and no comparative effectiveness results are available while recruitment continues.
- Pragmatic multicenter parallel-group open-label non-inferiority RCT comparing CADe-guided colonoscopy to pancolonic chromoendoscopy (virtual or dye spray).
- Eligible: adults >=18 with longstanding >=8 years IBD or any duration with primary sclerosing cholangitis involving >=1/3 colorectum in clinical remission undergoing surveillance.
- Primary outcome is visible colorectal neoplasia detected at colonoscopy; secondary includes mean number of CRN, high-risk CRN, procedural time, adverse events, endoscopist acceptance.
- Sample size 752 participants to demonstrate non-inferiority with 7.5% margin at one-sided alpha 2.5% and 80% power assuming 15% CRN rate in both groups.
- As of June 8, 2026, 19 of target 752 participants recruited; enrollment began April 2026 and study remains in active recruitment phase.
Current AI detection systems are not specifically trained for IBD-related lesions, limiting effectiveness for colorectal neoplasia detection in inflammatory bowel disease.
The rundown
The protocol describes central randomization by permuted blocks stratified by endoscopist, with primary analysis restricted to high-quality colonoscopy defined as adequate preparation, minimal inflammation, and complete intubation, and both per-protocol and intention-to-treat analyses planned.
The trial is registered as ACTRN12626000102370 and follows SPIRIT 2025 guidelines, noting that pancolonic chromoendoscopy is recommended over white light endoscopy alone but is poorly adopted due to technical and logistical limitations.
Sources
- Peer-reviewedBMC Gastroenterology2026-07-17
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The debate