Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study)

Launched by FUNDACIÓN PARA EL FOMENTO DE LA INVESTIGACIÓN SANITARIA Y BIOMÉDICA DE LA COMUNITAT VALENCIANA · Feb 25, 2024

Keywords

ClinConnect Summary

The EIIDISIA Study is a clinical trial that aims to find out how well a new technology called Computer Aided Detection (CADe) can help doctors identify abnormal changes, known as dysplasia, during colonoscopies in patients with long-term inflammatory bowel disease (IBD). This study will compare the effectiveness of colonoscopies assisted by this AI system to another method called virtual chromoendoscopy, which uses special lighting to highlight areas of concern. The goal is to see which method is better at finding dysplasia that could lead to cancer.

To participate in this study, you need to be an adult over 18 years old with a confirmed diagnosis of IBD for more than seven years. You should also have specific types of IBD, such as extensive ulcerative colitis or colon-only Crohn's disease. Participants will undergo a colonoscopy, and those who qualify will provide written consent before the procedure. It's important to know that individuals with a history of colorectal cancer, recent colonoscopies, or certain types of IBD will not be eligible. If you decide to participate, you'll be contributing to important research that could improve how dysplasia is detected in patients with IBD.

Gender

ALL

Eligibility 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).