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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03824418
Enrollment
210
Registered
2019-01-31
Start date
2016-05-09
Completion date
2018-10-01
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chromoendoscopy, Ulcerative Colitis

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

PROCEDURESurveillance colonoscopy with chromoendoscopy

Surveillance colonoscopy with chromoendoscopy

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

MeasureTime frameDescription
the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.during surveillance colonoscopythe proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.

Secondary

MeasureTime frameDescription
The proportion of patients in which at least one histological proven neoplastic lesion was detectedduring surveillance colonoscopyThe proportion of patients in which at least one histological proven neoplastic lesion was detected
The mean number of histological proven neoplastic lesions per patientduring surveillance colonoscopyThe mean number of histological proven neoplastic lesions per patient
The proportion of patients in which at least one histological proven sessile serrated lesion was detectedduring surveillance colonoscopyThe 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 patientduring surveillance colonoscopyThe 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 lesionduring surveillance colonoscopyDescription 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026