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

Inflammatory Bowel Diseases Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281392
• Other study ID #: CEIm: 106/23
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: November 15, 2026

Study information

• Verified date: February 2024
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: Antonio López-Serrano, PhD
• Phone: +0034656495490
• Email: anlopezs[@]comv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: November 15, 2026
• Est. primary completion date: November 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Dysplasia
• Hyperplasia
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Device:
• CADe system
Colonoscopy assisted by an artificial intelligence system (CADe).
• NBI
Virtual colonoscopy assisted by NBI

Locations

Country	Name	City	State
Spain	Antonio López-Serrano	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana	University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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
Primary	"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	Duration of endoscopic examination	Median (IQR) examination time (in minutes) (including total, insertion, and withdrawal time) required by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI	Immediately after the procedure