NCT04291976Completed
Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance
Back-to-back High-definition White Light Endoscopy Versus Single-pass High-definition White Light Endoscopy and Chromoendoscopy in IBD Surveillance
Source: ClinicalTrials.gov · Last updated 21 Nov 2023
Brief summary (registry, in English)
The current international guidelines for CRC surveillance in IBD recommend as first choice the use of chromoendoscopy, and as an alternative high-definition white light endoscopy (HDWLE) for optimal dysplasia detection, based on data from clinical trials. However, data on the superiority of CE over HDWLE are not consistent in literature. The investigators hypothesize that the better performance of CE in some clinical trials is the result of the associated longer procedural time and the fact that every colon segment is examined twice. Currently, no studies have been published evaluating the dysplastic yield of back-to back HDWLE compared to HDWLE with a single pass or CE in patients with IBD. In the present study, the investigators aim to compare the yield of dysplasia/CRC between 1) regular HDWLE, 2) HDWLE back-to-back, and 3) CE.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 563 (actual)
- First submitted
- 26 Feb 2020
- Start date
- 13 Mar 2020
- Primary completion date
- 23 May 2023
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT04291976
What you commit to
- Study type: Interventional
- Participants enrolled: 563
- From 13 Mar 2020 to the primary completion date, 23 May 2023
- 4 sites in 1 country
- 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
- Allergy or intolerance to methylene blue
Other
- Active colitis \> 20 cm and/or inflammation resulting in an insufficient surveillance procedure according to the endoscopist.
- Insufficient bowel cleansing (BBPS \<6)
- Refusing or incapable to agree with informed consent
- Pregnant women
- \> 50 % of the colon surgically removed
Who the study is looking for
- Signed informed consent
- Patients with inflammatory bowel disease, an estimated involvement of at least 30% of the colonic surface and a disease duration of at least 8 years (or any disease duration in case of concomitant primary sclerosing cholangitis).
- Previous assessable surveillance endoscopy \> 1 year
- Age \> 18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC, location AMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Utrecht University Medical Center Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.