Chromoendoscopy-guided confocal laser endomicroscopy in the surveillance of patients with Crohn*s disease
Completed
- Conditions
- Colon cancerdysplasia10017990
- Registration Number
- NL-OMON34757
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Patients diagnosed with Crohn*s colitis in remission, with at least 50 cm of the colon involved.
Indication for surveillance colonoscopy (disease duration of more than 8 years or diagnosed with concomitant primary sclerosing cholangitis)
Age >18 years
Exclusion Criteria
Contraindications (allergy, pregnancy or breastfeeding, severe cardiopulmonary disease or renal failure) for the use of intravenous fluorescein
Non-correctable coagulopathy that precludes taking biopsies (international normalized ratio >2; or platelet count <90*109)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of patients with neoplasia and the mean number of neoplastic<br /><br>lesions per patient.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- The diagnostic accuracy of CCLE for differentiating neoplastic from<br /><br>non-neoplastic mucosa in patients with Crohn*s disease. The proportion of<br /><br>neoplasia found in segments with known Crohn*s disease.<br /><br>- The diagnostic accuracy of CCLE to differentiate DALMs from ALMs.<br /><br>- The inter- and intraobserver variability assessing confocal images with and<br /><br>without matching endoscopic images. </p><br>