Clinical trial NCT03824418: The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis
Official title: The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis: an Observational Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Chromoendoscopy
Keywords: Surveillance
Chromoendoscopy
Dysplasia
Ulcerative Colitis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of the FIND-UC trial that undergo a follow surveillance colonoscopy

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.


Eligibility 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

Primary outcomes:
measure: the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.
timeFrame: during surveillance colonoscopy
Secondary outcomes:
measure: The proportion of patients in which at least one histological proven neoplastic lesion was detected
timeFrame: during surveillance colonoscopy
measure: The mean number of histological proven neoplastic lesions per patient
timeFrame: during surveillance colonoscopy
measure: The proportion of patients in which at least one histological proven sessile serrated lesion was detected
timeFrame: during surveillance colonoscopy
measure: The mean number of histological proven sessile serrated lesions per patient
timeFrame: during surveillance colonoscopy
measure: 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
timeFrame: during surveillance colonoscopy
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
state: Noord-Holland
Study officials:
References: