RecruitingNot ApplicableNCT01882205

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

Endoscopic Screening for Dysplasia in Patients With Longstanding Ulcerative Colitis: Classical Chromo-endoscopy Versus NBI , FICE and EPK-i.


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

402 participants

Start Date

May 1, 2008

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares different techniques for finding early cancer or pre-cancer changes during a bowel scope (colonoscopy) in people who have had ulcerative colitis (a chronic inflammatory bowel condition) for many years, since long-standing colitis increases the risk of colon cancer. **You may be eligible if...** - You have had ulcerative colitis for at least 8 years (or pancolitis for 8 years, or left-sided colitis for 10 years) - You had your last surveillance colonoscopy more than 1 year ago - You have signed a consent form **You may NOT be eligible if...** - You currently have active, severe ulcerative colitis - You have a personal history of colorectal cancer - You are allergic or intolerant to methylene blue (a dye used in the scope exam) - You are under 18 - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtual chromoendoscopy
PROCEDUREChromoendoscopy

Panchromocolonoscopy with methyleen blue 0.1%


Locations(5)

University Hospitals Leuven

Leuven, Belgium

H.-Hartziekenhuis Roeselare-Menen VZW

Roeselaere, Belgium

McGill University Health Center

Montreal, Canada

Copenhagen University Hospital Herlev

Copenhagen, Denmark

Academic Medical center Maastricht

Maastricht, Netherlands

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NCT01882205


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