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Active, not recruiting Not applicable

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

NCT06281392 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-11-15
Last updated
2025-08-15

Condition(s) studied

Inflammatory Bowel DiseasesDysplasia

Investigational drug(s) / intervention(s)

CADe systemNBI

CADe system: Colonoscopy assisted by an artificial intelligence system (CADe).

NBI: Virtual colonoscopy assisted by NBI

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • "Per lesion" dysplasia detection rate (DDR) — Immediately after the procedure
    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
  • "Per patient" dysplasia detection rate (DDR) — Immediately after the procedure
    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

Trial sites (1)

FacilityCityRegionStatus
Antonio López-Serrano Valencia Valencia

More Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06281392 on ClinicalTrials.gov ↗ ← All trials in Spain