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

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

Status

Active, not recruiting

Conditions

Dysplasia

Inflammatory Bowel Diseases

Treatments

Device: NBI

Device: CADe system

Study type

Interventional

Funder types

Other

Identifiers

NCT06281392

CEIm: 106/23

Details and patient eligibility

About

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).

Enrollment

122 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).