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

NCT ID: NCT03824418

Last Updated: 2019-01-31

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.

Detailed Description

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Conditions

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Ulcerative Colitis Chromoendoscopy

Keywords

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Surveillance Chromoendoscopy Dysplasia Ulcerative Colitis

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

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

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Prof. Evelien Dekker, MD, PhD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Academic Medical Centre

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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00001

Identifier Type: -

Identifier Source: org_study_id