Randomized comparison of endoscopic trimodal imaging versus chromoendoscopy guided confocal laser endomicroscopy as surveillance strategy for neoplasia in inflammatory bowel disease of the colon.
- Conditions
- Colon cancerdysplasia10017990
- Registration Number
- NL-OMON33215
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 235
Inclusion Criteria
Patients with inflammatory bowel disease for more than 8 years.
Patients older than 18 year.
Exclusion Criteria
Personal history of (partial) colectomy.
Contraindications for the use of intravenous fluorescein ( allergy, pregnancy or breastfeeding, sever cardiopulmonary disease or renal failure).
Currently known colonic neoplasia (e.g. referred patient or patients who refused treatment of neoplasia in the past).
Non-correctable coagulopathy that precludes taking biopsies (international normalized ratio >2 or platelet count < 90*10.9)
No informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare endoscopic trimodal imaging (ETMI) vs. chromoendoscopy-guided<br /><br>confocal laser endomicroscopy (CCLE) for differentiating neoplastic from<br /><br>non-neoplastic mucosa in patients with ulcerative colitis (UC). </p><br>
- Secondary Outcome Measures
Name Time Method <p>(1) Compare neoplasia detection rates of autofluorescence imaging (AFI) vs.<br /><br>chromoendoscopy (CE) and (2) identify diagnostic endoscopic markers for<br /><br>differentiation between dysplasia associated lesions/masses (DALMs) and<br /><br>adenoma-like masses (ALMs)</p><br>