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

NCT03824418 | Completed

• 1 other identifier: 00001
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Chromoendoscopy

Keywords

Surveillance; Chromoendoscopy; Dysplasia; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  during surveillance colonoscopy

• 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

  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

  during surveillance colonoscopy

Study Arms (2)

Chromoendoscopy follow-up

Procedure: Surveillance colonoscopy with chromoendoscopy

Autofluorescence follow-up

Procedure: Surveillance colonoscopy with chromoendoscopy

Interventions

Surveillance colonoscopy with chromoendoscopy PROCEDURE

Surveillance colonoscopy with chromoendoscopy

Autofluorescence follow-up; Chromoendoscopy follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of the FIND-UC trial that undergo a follow surveillance colonoscopy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Centre

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: January 31, 2019
• Study Start: May 9, 2016
• Primary Completion: May 9, 2018
• Study Completion: October 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (1)