The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis

Completed

• Conditions: Ulcerative Colitis; Chromoendoscopy
• Interventions: Procedure: Surveillance colonoscopy with chromoendoscopy

• Registration Number: NCT03824418
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

A recent multicentre randomised controlled trial compared autofluorescence imaging (AFI) with CE for dysplasia detection in colonoscopy surveillance of patients with longstanding UC (FIND-UC). In this study, CE detected significantly more dysplastic lesions per patient compared with AFI. It is unclear whether this increased dysplasia detection also translates to a reduction of dysplasia at follow-up colonoscopy. The aim of this pre-specified study is therefore to prospectively determine whether there is a difference in dysplasia detection at follow-up colonoscopy between UC patients who were randomized to AFI or CE at index colonoscopy for the FIND-UC trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-09
• Study First Submitted: 2018-03-09
• Primary Completion: 2018-05-09
• Study Completion: 2018-10-01
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Study First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chromoendoscopy follow-up	Surveillance colonoscopy with chromoendoscopy	-
Autofluorescence follow-up	Surveillance colonoscopy with chromoendoscopy	-

Primary Outcome Measures

Name	Time	Method
the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.	during surveillance colonoscopy	the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.

Secondary Outcome Measures

Name	Time	Method
The proportion of patients in which at least one histological proven neoplastic lesion was detected	during surveillance colonoscopy	The proportion of patients in which at least one histological proven neoplastic lesion was detected
The proportion of patients in which at least one histological proven sessile serrated lesion was detected	during surveillance colonoscopy	The proportion of patients in which at least one histological proven sessile serrated lesion was detected
The mean number of histological proven neoplastic lesions per patient	during surveillance colonoscopy	The mean number of histological proven neoplastic lesions per patient
The mean number of histological proven sessile serrated lesions per patient	during surveillance colonoscopy	The mean number of histological proven sessile serrated lesions per patient
Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesion	during surveillance colonoscopy	Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesions detected during surveillance colonoscopy.

Trial Locations

Locations (1)

Academic Medical Centre; 🇳🇱 Amsterdam, Noord-Holland, Netherlands