Comparison Between Chromoendoscopy and Virtual Chromoendoscopy (NBI, I-scan, FICE) for Detection of Neoplasia in Long Standing Ulcerative Colitis
Not applicable · Testing Virtual chromoendoscopy and Chromoendoscopy · 5 sites · Universitaire Ziekenhuizen KU Leuven
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Virtual chromoendoscopy (a device) and Chromoendoscopy (a procedure) as a way to diagnose or measure disease. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 402 participants are expected to take part.
- Start date: 2008-05.
- Main results expected around 2018-12 (estimate from the record).
- 5 study sites listed (5 marked recruiting) in Belgium, Canada, Denmark and Netherlands.
Main thing being measured
- The difference in total number of neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy (The primary endpoint can be assessed when pathology results are available : 2 weeks after endoscopy)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Collaborators | H.-Hartziekenhuis Roeselare-Menen VZW, Belgium.; McGill University; Maastricht University Medical Center; Copenhagen University Hospital at Herlev |
| Enrollment | 402 (estimated) |
| Start date | 2008-05 |
| Primary completion (est.) | 2018-12 |
| First posted | 2013-06-20 |
| Last updated | 2024-07-10 |
| Official title | Endoscopic Screening for Dysplasia in Patients With Longstanding Ulcerative Colitis: Classical Chromo-endoscopy Versus NBI , FICE and EPK-i. |
| ClinicalTrials.gov ID | NCT01882205 |
Interventions
- Virtual chromoendoscopy (Device)
- Chromoendoscopy (Procedure)
Panchromocolonoscopy with methyleen blue 0.1%
Full eligibility criteria (from the record)
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
Locations (5)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.