Chromoendoscopy, Ulcerative Colitis
Conditions
Keywords
Surveillance, Chromoendoscopy, Dysplasia, Ulcerative Colitis
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.
Interventions
Surveillance colonoscopy with chromoendoscopy
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 mean number of histological proven neoplastic lesions per patient | during surveillance colonoscopy | The mean number of histological proven neoplastic lesions per patient |
| 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 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. |
Countries
Netherlands