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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-09

Study Completion Date

2018-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis Chromoendoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chromoendoscopy follow-up

Surveillance colonoscopy with chromoendoscopy

Intervention Type PROCEDURE

Surveillance colonoscopy with chromoendoscopy

Autofluorescence follow-up

Surveillance colonoscopy with chromoendoscopy

Intervention Type PROCEDURE

Surveillance colonoscopy with chromoendoscopy

Interventions

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Surveillance colonoscopy with chromoendoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

\- Patients that where included in the previous FIND-UC trial

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Patients who not receive their surveillance colonoscopy with CE
* Patients who not undergo their surveillance colonoscopy within 3 months of the surveillance recommendations

Withdrawal of individual subjects

A patient will be excluded from the study if any of the following events occur:

* Withdrawal of informed consent
* The patient requests to be discontinued from the study
* The bowel preparation is scored as Boston Bowel Preparation Scale \<6
* Incomplete colonoscopy because the endoscopist is unable to intubate the cecum during the colonoscopy
* The Mayo-score \> 1 in at least in one of the bowel segments

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No