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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824418
• Other study ID #: 00001
• Status: Completed
• Start date: May 9, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: January 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 1, 2018
• Est. primary completion date: May 9, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chromoendoscopy
• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Procedure:
• Surveillance colonoscopy with chromoendoscopy
Surveillance colonoscopy with chromoendoscopy

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre	Amsterdam	Noord-Holland

Sponsors (1)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The mean number of histological proven neoplastic lesions per patient	The mean number of histological proven neoplastic lesions per patient	during surveillance colonoscopy
Secondary	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
Secondary	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
Secondary	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