A new endoscopic technique for the detection of possible malignant mucosal changes in patients with Crohn's disease.
- Conditions
- Crohn's, IBD, dysplasia, chromoendoscopy, endomicroscopy. Crohn, IBD, dysplasie, chromoendoscopie, endomicroscopie
- Registration Number
- NL-OMON20621
- Lead Sponsor
- Academic Medical Centre, the Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 101
Inclusion Criteria
1. Patients diagnosed with Crohn’s colitis that are in remission;
2. Patients who have Crohn’s disease in at least 50 cm of the colon, based on clinical symptoms, endoscopy and histopathological diagnosis;
Exclusion Criteria
1. Contraindications (allergy, pregnancy or breastfeeding, severe cardiopulmonary disease or pre-existent renal disease) for the use of intravenous fluorescein;
2. Known non-correctable coagulopathy that precludes taking biopsies (international normalized ratio >2; or platelet count <90*109). Patients who take anticoagulants will have their international normalized ratio evaluated prior to the colonoscopy;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of patients with neoplasia;<br /><br>2. Mean number of neoplastic lesions per included patient.<br>
- Secondary Outcome Measures
Name Time Method