Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana50 enrolled

Overview

Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Enrollment

Conditions

Ulcerative Colitis Dysplasia

Interventions

DiscoveryTMDEVICE

Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).

iSCANDEVICE

Virtual colonoscopy assisted by iSCAN

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ulcerative Colitis confirmed by endoscopy and histology. * Involvement 30% of the colonic surface (or any extent if concomitant with PSC). * Duration of the disease \>7 years (or any duration if concomitant with PSC). Exclusion Criteria: * Personal history of colorectal cancer or high-grade dysplasia. * Previous colectomy (partial or complete). * Coagulopathy that prevents biopsies or polypectomy. * Colonoscopy performed in the previous 6 months. * Pregnant or nursing women. * Inadequate bowel preparation. * Presence of endoscopic Ulcerative Colitis activity. * Colonic stenosis and incomplete colonoscopy.

Locations (1)

Antonio López-Serrano

Valencia, Spain

Outcomes

Primary Outcomes

"Per lesion" dysplasia detection rate (DDR)

Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN in patients with long-standing Ulcerative Colitis who undergo surveillance colonoscopy.

Time frame: 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 Ulcerative Colitis included in the study detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN.

Time frame: Immediately after the procedure.

Data from ClinicalTrials.gov

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