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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis; Chromoendoscopy
• Intervention / Treatment: Procedure: Surveillance colonoscopy with chromoendoscopy

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Academic Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chromoendoscopy follow-up	Procedure: Surveillance colonoscopy with chromoendoscopy; Surveillance colonoscopy with chromoendoscopy
Autofluorescence follow-up	Procedure: Surveillance colonoscopy with chromoendoscopy; Surveillance colonoscopy with chromoendoscopy

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2016
• Primary Completion (Actual): May 9, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Surveillance; Chromoendoscopy; Dysplasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No