Inflammatory Bowel Diseases Clinical Trial
Official title:
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)
Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD).
Status | Recruiting |
Enrollment | 122 |
Est. completion date | November 15, 2026 |
Est. primary completion date | November 15, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Spain | Antonio López-Serrano | Valencia |
Lead Sponsor | Collaborator |
---|---|
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana | University of Valencia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | "Per lesion" dysplasia detection rate (DDR) | Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI in patients with long-standing Inflammatory bowel disease who undergo surveillance colonoscopy | Immediately after the procedure | |
Primary | "Per patient" dysplasia detection rate (DDR) | Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Inflammatory bowel disease included in the study detected by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI | Immediately after the procedure | |
Secondary | Duration of endoscopic examination | Median (IQR) examination time (in minutes) (including total, insertion, and withdrawal time) required by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI | Immediately after the procedure |
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