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

NCT06281392 | Active Not Recruiting DMC

• 1 other identifier: CEIm: 106/23
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Inflammatory Bowel Diseases; Dysplasia

Keywords

Inflammatory Bowel Disease; Virtual chromoendoscopy; NBI; CADe; Dysplasia

Outcome Measures

Primary Outcomes (2)

• "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

• "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 Outcomes (1)

• Duration of endoscopic examination

  Immediately after the procedure

Study Arms (2)

Colonoscopy assisted by CADe

EXPERIMENTAL

Device: CADe system

Virtual Colonoscopy with NBI

ACTIVE COMPARATOR

Device: NBI

Interventions

CADe system DEVICE

Colonoscopy assisted by an artificial intelligence system (CADe).

Colonoscopy assisted by CADe

NBI DEVICE

Virtual colonoscopy assisted by NBI

Virtual Colonoscopy with NBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: lead
• University of Valencia: collaborator

Study Sites (1)

Antonio López-Serrano

Valencia, Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Antonio López-Serrano, PhD

  Hospital Universitari Dr. Peset, Valencia (Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endoscopy Section

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: February 28, 2024
• Study Start: November 15, 2023
• Primary Completion: June 20, 2025
• Study Completion: November 20, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)