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NCT Number: NCT03824418

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

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.

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Key information

Conditions

Ulcerative Colitis Chromoendoscopy Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Centre

Amsterdam, North Holland, 1105AZ, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surveillance colonoscopy with chromoendoscopy

Procedure

Surveillance colonoscopy with chromoendoscopy

Primary outcomes

  1. the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.

    Time frame: during surveillance colonoscopy

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

Secondary outcomes

  1. The proportion of patients in which at least one histological proven neoplastic lesion was detected

    Time frame: during surveillance colonoscopy

    The proportion of patients in which at least one histological proven neoplastic lesion was detected

  2. The mean number of histological proven neoplastic lesions per patient

    Time frame: during surveillance colonoscopy

    The mean number of histological proven neoplastic lesions per patient

  3. The proportion of patients in which at least one histological proven sessile serrated lesion was detected

    Time frame: during surveillance colonoscopy

    The proportion of patients in which at least one histological proven sessile serrated lesion was detected

  4. The mean number of histological proven sessile serrated lesions per patient

    Time frame: during surveillance colonoscopy

    The mean number of histological proven sessile serrated lesions per patient

  5. 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

    Time frame: 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 lesions detected during surveillance colonoscopy.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2019
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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