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

Last updated: August 12, 2025
Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Precancerous Condition

Gastrointestinal Diseases And Disorders

Treatment

NBI

CADe system

Clinical Study ID

NCT06281392
CEIm: 106/23
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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), Extensivecolitis (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 extentof colonic involvement and disease duration.

  • Written consent from the patient to undergo colonoscopy (signed informed consent).

Exclusion

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 (MontrealE1).

  • 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 MayoScore ≥ 2. 2) For CD: Simplified Endoscopic Activity Score (SES-CD) > 5.

  • Incomplete lower digestive endoscopy (failure to reach the cecum).

Study Design

Total Participants: 122
Treatment Group(s): 2
Primary Treatment: NBI
Phase:
Study Start date:
November 15, 2023
Estimated Completion Date:
November 20, 2025

Connect with a study center

  • Antonio López-Serrano

    Valencia, 46017
    Spain

    Site Not Available

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