Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT01882205

Comparison Between Chromoendoscopy and Virtual Chromoendoscopy (NBI, I-scan, FICE) for Detection of Neoplasia in Long Standing Ulcerative Colitis

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-10

402

Participants Needed

5

Research Sites

1017 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

H

H.-Hartziekenhuis Roeselare-Menen VZW, Belgium.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the rectum is increased and therefore patients should be enrolled in a surveillance program eight years after the diagnosis. Until today, official international guidelines for endoscopic screening in patients with ulcerative colitis advise to take 4 biopsies every 10 centimeters (with a minimum of 32) and of each suspected visible lesion. These guidelines are merely based on consensus during expert opinion meetings rather than evidence based. Recent studies have shown that chromo-endoscopy guided biopsies significantly reduced the number of biopsies for each procedure and detected more neoplastic lesions. Chromo-endoscopy is therefore considered the gold standard in this study in which we want to compare it to the performance and efficiency of new endoscopic imaging techniques. Narrow-Band Imaging (NBI) selectively uses certain wavelengths of the visible light leading to a shift in the excitation spectrum towards blue light. The first studies with NBI showed that the additional value of NBI in the detection of neoplastic lesions is comparable to chromo-endoscopy, but time saving and easier to perform. The Fujinon Intelligent Chromo-Endoscopy (FICE) system uses a similar theoretical principal as NBI but this is achieved via the use of post hoc computer algorithms, applying different filters to the stored endoscopic images and enabling a theoretically endless number of combinations of filters that can be used. The Pentax I-scan system also allows post hoc modification of the images. On the one hand, surface enhancement enables to better highlight mucosal changes. Spectral modification allows to apply different modes in analogy with to FICE system. These new imaging techniques have a theoretical advantage which is extendedly used for sales purposes but has however so far not been proven in ulcerative colitis patients. We want to test their clinical use in the screening for neoplastic lesions in patients with long standing ulcerative colitis.

CONDITIONS

Official Title

Comparison Between Chromoendoscopy and Virtual Chromoendoscopy (NBI, I-scan, FICE) for Detection of Neoplasia in Long Standing Ulcerative Colitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with longstanding ulcerative colitis (8 years after diagnosis for pancolitis or 10 years after diagnosis for left-sided colitis)
  • Signed informed consent form
  • Previous surveillance endoscopy more than 1 year ago
Not Eligible

You will not qualify if you...

  • Active ulcerative colitis affecting more than 20 cm from the anus
  • Personal history of colorectal cancer
  • Allergy or intolerance to methylene blue
  • Refusing or unable to provide informed consent
  • Age younger than 18 years
  • Pregnant women

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Trial Site Locations

Total: 5 locations

1

University Hospitals Leuven

Leuven, Belgium, 3000

Actively Recruiting

2

H.-Hartziekenhuis Roeselare-Menen VZW

Roeselaere, Belgium, 8800

Actively Recruiting

3

McGill University Health Center

Montreal, Canada

Actively Recruiting

4

Copenhagen University Hospital Herlev

Copenhagen, Denmark, 2730

Actively Recruiting

5

Academic Medical center Maastricht

Maastricht, Netherlands, 6219 NG

Actively Recruiting

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Research Team

V

Vera Ballet

CONTACT

H

Hilde Willekens

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

6

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Comparison Between Chromoendoscopy and Virtual Chromoendoscopy (NBI, I-scan, FICE) for Detection of Neoplasia in Long Standing Ulcerative Colitis | DecenTrialz