NCT01882205Recruiting
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.
Source: ClinicalTrials.gov · Last updated 10 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 402 (estimated)
- First submitted
- 12 Jun 2013
- Start date
- May 2008
- Primary completion date
- Dec 2018
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Ulcerative colitis
- NCT number
- NCT01882205
What you commit to
- Study type: Interventional
- Planned participants: 402
- From May 2008 to the primary completion date, Dec 2018
- 5 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Personal history of colorectal cancer
- Allergy or intolerance to methylene blue
Age
- Age younger than 18 years
Other
- Active ulcerative colitis, \> 20 cm from the margo ani
- Refusing or incapable to agree with informed consent
- Pregnant women
Who the study is looking for
- Patients with longstanding ulcerative colitis ( 8 years after diagnosis or pancolitis and 10 years after diagnosis of left-sided colitis)
- Signed informed consent form
- Previous surveillance endoscopy \> 1 year
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| H.-Hartziekenhuis Roeselare-Menen VZW Coordinator of this site? Confirm its status | Roeselaere | Belgium | Recruiting |
| McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Copenhagen University Hospital - Herlev Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Academic Medical center Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.