Using AI to detect dysplasia in patients with inflammatory bowel disease
Effect of an Artificial Intelligence System on the Detection of Dysplasia During Colonoscopy in Patients With Long-standing Inflammatory Bowel Disease: a Randomized Study (EIIDISIA Study)
This study is testing whether an AI tool or a special imaging technique is better at spotting early signs of cancer in the colons of people with long-term inflammatory bowel disease during a colonoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT06281392 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a Computer Aided Detection (CADe) system during colonoscopy compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) for identifying dysplasia in patients with long-standing inflammatory bowel disease (IBD). The study involves randomizing participants to receive one of the two interventions during their colonoscopy. The goal is to determine which method is more effective in detecting dysplastic changes in the colon, which can be precursors to cancer. Participants must meet specific eligibility criteria related to their IBD diagnosis and disease duration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of inflammatory bowel disease and a disease duration of more than 7 years.
Not a fit: Patients with a personal history of colorectal cancer or those who have had a colectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve early detection of dysplasia in IBD patients, potentially leading to better management and outcomes.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for dysplasia detection, but this specific approach using AI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: * Adults (age ≥18 years). * Patients with IBD meeting the following criteria: * Diagnosis of IBD confirmed by clinical and histological evidence. * Disease extent (Montreal classification): 1) For Ulcerative Colitis (UC), Extensive colitis (E3): involvement proximal to the splenic flexure; or, Left-sided colitis (E2): involvement distal to the splenic flexure. 2) For Crohn's Disease (CD): Colon-only involvement (L2); or, Ileocolonic involvement (L3). * Disease duration \> 7 years. * Patients with concommitant Primary Sclerosing Cholangitis, regardless of the extent of colonic involvement and disease duration. * Written consent from the patient to undergo colonoscopy (signed informed consent). EXCLUSION CRITERIA: * Personal history of colorectal cancer (CRC). * Previous colectomy (partial or complete). * Coagulopathy preventing biopsy or polypectomy/mucosal resection. * Colonoscopy performed in the last 6 months. * Pregnant or lactating women. * Ulcerative colitis with involvement limited to the rectum or Proctitis (Montreal E1). * Inadequate colonic preparation due to uncleavable fecal residue during colonoscopy: Boston Bowel Preparation Scale (BBPS) = 0 or 1 in any colon segment. * Presence of inflammatory activity due to IBD on endoscopy:1) For UC: Endoscopic Mayo Score ≥ 2. 2) For CD: Simplified Endoscopic Activity Score (SES-CD) \> 5. * Incomplete lower digestive endoscopy (failure to reach the cecum).
Where this trial is running
Valencia
- Antonio López-Serrano — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio López-Serrano, PhD — Hospital Universitari Dr. Peset, Valencia (Spain)
- Study coordinator: Antonio López-Serrano, PhD
- Email: anlopezs@comv.es
- Phone: +0034656495490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.