Comparing two endoscopic techniques for detecting cancer in ulcerative colitis patients
Endoscopic Screening for Dysplasia in Patients With Longstanding Ulcerative Colitis: Classical Chromo-endoscopy Versus NBI , FICE and EPK-i.
This study is testing if two different endoscopy techniques can better find cancer in people with long-term ulcerative colitis while reducing the need for random biopsies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 402 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 5 sites (Leuven and 4 other locations) |
| Trial ID | NCT01882205 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of chromoendoscopy and virtual chromoendoscopy techniques in detecting neoplasia in patients with longstanding ulcerative colitis. Patients enrolled in this study will undergo surveillance endoscopies to evaluate the performance of these imaging methods against the current standard of care, which involves random biopsies. The study seeks to determine if chromoendoscopy, which uses contrast agents, can reduce the number of biopsies needed while improving the detection of cancerous lesions. The findings could lead to more efficient and cost-effective surveillance protocols for patients at risk of colon cancer due to ulcerative colitis.
Who should consider this trial
Good fit: Ideal candidates are patients with longstanding ulcerative colitis who have been diagnosed for at least 8 years.
Not a fit: Patients with active ulcerative colitis or a personal history of colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cancer detection rates and reduced need for unnecessary biopsies in patients with ulcerative colitis.
How similar studies have performed: Previous studies have shown that chromoendoscopy can enhance dysplasia detection, suggesting that this approach may be effective, though the specific comparison with virtual chromoendoscopy is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Active ulcerative colitis, \> 20 cm from the margo ani * Personal history of colorectal cancer * Allergy or intolerance to methylene blue * Refusing or incapable to agree with informed consent * Age younger than 18 years * Pregnant women
Where this trial is running
Leuven and 4 other locations
- University Hospitals Leuven — Leuven, Belgium (Recruiting)
- H.-Hartziekenhuis Roeselare-Menen VZW — Roeselaere, Belgium (Recruiting)
- McGill University Health Center — Montreal, Canada (Recruiting)
- Copenhagen University Hospital Herlev — Copenhagen, Denmark (Recruiting)
- Academic Medical center Maastricht — Maastricht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Raf Bisschops, MD PhD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Vera Ballet
- Email: vera.ballet@uzleuven.be
- Phone: +3216341601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.