None listed
Conditions
Brief summary
People with inflammatory bowel disease that affects the colon such as ulcerative colitis and certain forms of Crohn’s disease have about 1.5 to 2 times higher risk of developing colorectal cancer compared to people without inflammatory bowel disease. This is mainly because long-term inflammation in the colon can damage cells and increase the chances of cancer. The cancers that develop in inflammatory bowel disease can also be harder to spot, since they often appear flatter and less obvious. Traditionally, colonoscopies have used standard white light imaging. But for people with inflammatory bowel disease, techniques that enhance the view of the colon such as chromoendoscopy, where dye is sprayed onto the lining are recommended because they can better reveal subtle changes. More recently, virtual chromoendoscopy (a digital version without dye) has become a practical alternative, though both methods require extra training and careful preparation, so they aren’t widely used. This has left a gap in surveillance quality, with many doctors still relying only on standard methods. However, new high-definition scopes and technologies like linked color imaging and artificial intelligence-based tools are showing promise in improving detection rates without the challenges of older techniques. A large clinical trial is planned to compare these newer approaches with traditional chromoendoscopy in inflammatory bowel disease patients, with the goal of improving outcomes and making advanced imaging more widely accepted in routine care.
Interventions
This will be a pragmatic, multicenter, parallel-group, open-label, non-inferiority randomized controlled pilot trial. Study participants will be allocated to one of two groups using central block randomization, stratified by study investigator: pancolonic computer-aided detection white light endoscopy or linked colour imaging (intervention group) or pancolonic virtual chromoendoscopy (blue light imaging) or dye spray chromoendoscopy with no computer-aided detection at the discretion of the inves
This will be a pragmatic, multicenter, parallel-group, open-label, non-inferiority randomized controlled pilot trial. Study participants will be allocated to one of two groups using central block randomization, stratified by study investigator: pancolonic computer-aided detection white light endoscopy or linked colour imaging (intervention group) or pancolonic virtual chromoendoscopy (blue light imaging) or dye spray chromoendoscopy with no computer-aided detection at the discretion of the investigator (standard of care group) during colonoscope withdrawal. Investigators will be permitted to perform pre-specified (prior to randomization) non-targeted biopsies in either group for surveillance (to identify indistinct flat colorectal neoplams) or staging (to identify microscopic disease activity) purposes, within reasonable standards of care. All study procedures will be performed by experienced gastroenterologists with expertise in colorectal inflammatory bowel disease surveillance (including 30 or more exams with either adjunct) in their clinic. The duration of the intervention is highly variable, typically ranging from 6-30 minutes of withdrawal time but extending based on procedural difficulty, colonoscope withdrawal challenges, and number of potential lesions flagged by CADe requiring inspection or resection. Frequency constitutes a one-time intervention per surveillance episode, aligned with guidelines for high-risk populations like PSC-IBD. Strategies to assess or monitor adherence/fidelity across sites include: • Standardized training protocols with pre-procedure certification videos and competency checklists for CADe system activation, withdrawal technique, and minimum inspection time logging. • Real-time procedure video recording with centralized AI audit of CADe bounding box acknowledgments, false-positive response rates, and withdrawal time metrics via automated software analysis. • Post-procedure endoscopist logs cross-verified against device telemetry (e.g., detection timestamps) and patient-level outcomes like adenoma detection rate (ADR), with site-specific feedback dashboards and quarterly fidelity audits.
Sponsors
University of Alberta
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults (18 years of age or older) with a diagnosis of colorectal inflammatory bowel disease of at least 8 years duration (or any duration if concomitant primary sclerosing cholangitis), historically involving at least 1/3 of the colorectum, who are in clinical remission, defined as no rectal blood loss and no significant lower gastrointestinal symptoms concerning for flare: pMayo equal or less than 2 (rectal bleeding score equla to 0) or Harvey-Bradshaw Index less than 5, or biochemical remission, defined as normal C-reactive protein/fecal calprotectin, or clinical remission per endoscopist 2. Scheduled to undergo surveillance colonoscopy
Exclusion criteria
1. Excluded prior to randomization if conditions for a high-quality exam are not met such as significant macroscopic inflammation ( 5 mm) ulcers, spontaneous bleeding or moderate to severe friability, intubation of the entire colorectum and presence of good to excellent bowel preparation following intraprocedural cleansing (Boston Bowel Preparation Score (BBPS) of 2 or more in each segment), 2. Refusing or incapable to agree with informed consent 3. Pregnant females 4. More than 50 % of the colon surgically removed
Outcome results
None listed