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

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Dysplasia
• Intervention / Treatment: Device: CADe system; Device: NBI

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio López-Serrano, PhD; Phone Number: +0034656495490; Email: anlopezs@comv.es
• Study Contact Backup: Name: Antonio López-Serrano, PhD; Phone Number: +0034963188700; Email: anlopezs@comv.es

Study Locations

• Spain
  • Valencia, Spain, 46017
    • Recruiting
    • Antonio López-Serrano
    • Contact: Antonio López-Serrano, Ph.D.; Phone Number: 0034656495490; Email: anlopezs@comv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colonoscopy assisted by CADe	Device: CADe system; Colonoscopy assisted by an artificial intelligence system (CADe).
Active Comparator: Virtual Colonoscopy with NBI	Device: NBI; Virtual colonoscopy assisted by NBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Collaborators: University of Valencia
• Investigators: Principal Investigator: Antonio López-Serrano, PhD, Hospital Universitari Dr. Peset, Valencia (Spain)

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; Dysplasia; NBI; Virtual chromoendoscopy; CADe
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Hyperplasia; Intestinal Diseases
• Other Study ID Numbers: CEIm: 106/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No