Clinical trial NCT06281392: Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Dysplasia
Keywords: Inflammatory Bowel Disease
Virtual chromoendoscopy
NBI
CADe
Dysplasia
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2024-02-28
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).


Eligibility criteria: 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).

Primary outcomes:
measure: "Per lesion" dysplasia detection rate (DDR)
timeFrame: Immediately after the procedure
measure: "Per patient" dysplasia detection rate (DDR)
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Duration of endoscopic examination
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Antonio López-Serrano
Study officials:
affiliation: Hospital Universitari Dr. Peset, Valencia (Spain)
name: Antonio López-Serrano, PhD
role: PRINCIPAL_INVESTIGATOR
References: