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

Not Applicable

Completed

• Conditions: Ulcerative Colitis; Dysplasia
• Interventions: Device: iSCAN; Device: DiscoveryTM

• Registration Number: NCT05171634
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-05
• Primary Completion: 2021-05-18
• Study Completion: 2021-05-18
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2021-12-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-08
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Virtual Colonoscopy with iSCAN	iSCAN	-
Colonoscopy assisted by DiscoveryTM	DiscoveryTM	-

Primary Outcome Measures

Name	Time	Method
"Per patient" dysplasia detection rate (DDR)	Immediately after the procedure.	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.
"Per lesion" dysplasia detection rate (DDR)	Immediately after the procedure.	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.

Trial Locations

Locations (1)

Antonio López-Serrano; 🇪🇸 Valencia, Spain