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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2025-11-20

Brief Summary

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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).

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Detailed Description

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Conditions

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Inflammatory Bowel Diseases Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Colonoscopy assisted by CADe

Group Type EXPERIMENTAL

CADe system

Intervention Type DEVICE

Colonoscopy assisted by an artificial intelligence system (CADe).

Virtual Colonoscopy with NBI

Group Type ACTIVE_COMPARATOR

NBI

Intervention Type DEVICE

Virtual colonoscopy assisted by NBI

Interventions

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CADe system

Colonoscopy assisted by an artificial intelligence system (CADe).

Intervention Type DEVICE

NBI

Virtual colonoscopy assisted by NBI

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No