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NCT Number: NCT06281392

Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antonio López-Serrano

Valencia, 46017, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CADe system

Device

Colonoscopy assisted by an artificial intelligence system (CADe).

NBI

Device

Virtual colonoscopy assisted by NBI

Primary outcomes

  1. "Per lesion" dysplasia detection rate (DDR)

    Time frame: 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

  2. "Per patient" dysplasia detection rate (DDR)

    Time frame: 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

Secondary outcomes

  1. Duration of endoscopic examination

    Time frame: Immediately after the procedure

    Median (IQR) examination time (in minutes) (including total, insertion, and withdrawal time) required by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI

Sponsors and collaborators

Lead sponsor

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Other

Collaborators

  • University of Valencia

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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