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COMPLETED
NCT07694362
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Narrow Band Imaging Versus Artificial Intelligence for Colonic Surveillance in Inflammatory Bowel Disease

Sponsor: Vall d'Hebron Institute Research

View on ClinicalTrials.gov

Summary

Patients with inflammatory bowel disease (IBD) - ulcerative colitis or Crohn's disease - have a higher risk of developing colorectal cancer than the general population. For this reason, regular colonoscopies are recommended to look for early warning signs, such as abnormal areas of tissue called dysplasia, which can develop into cancer over time. Finding these abnormal areas during colonoscopy can be difficult because IBD causes ongoing inflammation that can make the bowel mucosa look irregular, hiding subtle changes. Doctors currently use a technique called narrow-band imaging (NBI), a special light setting on the colonoscope that enhances the visibility of the bowel, to help spot these areas more easily. A newer tool, artificial intelligence (AI)-assisted detection, has shown promise in helping doctors find more polyps during routine colonoscopies in the general population. However, this AI tool was developed and tested mostly in people without IBD, so it is not yet known whether it works as well in people with IBD, whose bowel can look very different due to chronic inflammation. This study will directly compare the AI tool (CADe; ENDO-AID, Olympus) with narrow-band imaging to see which one is better at finding abnormal areas during colonoscopy in patients with long-standing ulcerative colitis or Crohn's disease who are having their routine cancer surveillance exam. Each participant will have one colonoscopy in which the bowel is examined twice in a row, once with each technique, by two different doctors, in random order. This lets researchers compare both methods directly within the same patient, which is the fairest comparison. The study aims to enroll 60 patients at Vall d'Hebron University Hospital in Barcelona, Spain. Researchers hope the results will help determine whether AI tools - which are widely available and easier to use than NBI - can be a reliable alternative for IBD surveillance, potentially making this important cancer-screening exam more accessible in the future.

Official title: Narrow Band Imaging Versus Artificial Intelligence for Colonic Surveillance in Inflammatory Bowel Disease: a Prospective, Randomized, Crossover Study The CLEAR-IBD Trial (Colorectal Lesion Evaluation Assisted by Real-time AI in Inflammatory Bowel Disease)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-01-01

Completion Date

2026-03-01

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

DEVICE

ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device)

Each participant was examined by two endoscopists with expertise in endoscopic surveillance in IBD on the same day consecutively in a randomized manner. Both endoscopists alternated between AI and NBI. Endoscopist 1 evaluated the entire colon using either AI -ENDO-AID CADe System (Olympus, Tokyo, Japan)- or NBI. Before lesion assessment, Endoscopist 1 first confirmed endoscopic remission, defined as a Mayo endoscopic score and a Simple Endoscopic Score for Crohn's Disease (SES-CD) for UC and CD, respectively, of 0. Then, lesions were documented and managed accordingly - resection or biopsy. Endoscopist 2, blinded to the previous findings, re-examined the entire colon with the alternate method, documented additional findings, and treated any lesions missed by Endoscopist 1. Both endoscopists performed the same number of explorations with NBI and AI as first or second exploration. High-definition endoscopes and the same processor were used for all procedures (Olympus CF-- HQ19).

Locations (1)

Vall d'Hebron University Hospital

Barcelona, Catalonia, Spain