Back-to-back high-definition white light endoscopy versus single-pass high-definition white light endoscopy and chromoendoscopy in IBD surveillance (HELIOS study)
Recruiting
- Conditions
- inflammatory bowel diseases1001796910017987
- Registration Number
- NL-OMON49570
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 560
Inclusion Criteria
- 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
Exclusion Criteria
- Active colitis > 20 cm and/or inflammation resulting in an insufficient
surveillance procedure according to the endoscopist.
- Allergy or intolerance to methylene blue
- Insufficient bowel cleansing (BBPS <6)
- Refusing or incapable to agree with informed consent
* Pregnant women
* > 50 % of the colon surgically removed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The detection rate of neoplasia (i.e. dysplasia and CRC) with the different<br /><br>endoscopic modalities </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Number of all lesions for each technique.<br /><br>2. Number of dysplastic lesions for each technique.<br /><br>3. Characteristics of lesions: Kudo classification, Paris classification,<br /><br>location, size<br /><br>4. Number of lesions detected at first and second examination (only in group<br /><br>back-to-back HDWLE)<br /><br>5. Duration of total endoscopic procedure time and endoscopic procedure time<br /><br>during withdrawal for each technique.<br /><br>6. Number of biopsies taken in the different groups.</p><br>