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

Study Overview
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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.

Official Title
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The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis: an Observational Follow-up Study

Conditions
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Ulcerative Colitis, Chromoendoscopy

Intervention / Treatment
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* Procedure: Surveillance colonoscopy with chromoendoscopy


Participation Criteria
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Eligibility Criteria
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Patients are eligible for inclusion in this study when they meet the following criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chromoendoscopy follow-up<br> | Procedure: Surveillance colonoscopy with chromoendoscopy<br>* Surveillance colonoscopy with chromoendoscopy<br>|
| Autofluorescence follow-up<br> | Procedure: Surveillance colonoscopy with chromoendoscopy<br>* Surveillance colonoscopy with chromoendoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy. | the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy. | during surveillance colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 neoplastic lesion was detected | during surveillance colonoscopy | 
| The mean number of histological proven neoplastic lesions per patient | The mean number of histological proven neoplastic lesions per patient | during surveillance colonoscopy | 
| The proportion of patients in which at least one histological proven sessile serrated lesion was detected | The proportion of patients in which at least one histological proven sessile serrated lesion was detected | during surveillance colonoscopy | 
| The mean number of histological proven sessile serrated lesions per patient | The mean number of histological proven sessile serrated lesions per patient | 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 lesion | 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. | during surveillance colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surveillance, Chromoendoscopy, Dysplasia, Ulcerative Colitis