CLE for Differential Diagnosis of IBD
Completed
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Device: Endomicroscopy
- Registration Number
- NCT02238665
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
- equal or above 18 years of age
- ability to provide written informed consent
- well-established diagnosis of CD or UC
Exclusion Criteria
- history of IBD reclassification in the last 3 years
- Boston Bowel Preparation Scale score's < 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon)
- inability to provide written informed consent
- severe uncontrolled coagulopathy
- impaired renal function
- pregnancy or breast feeding
- active gastrointestinal bleeding
- known allergy to fluorescein
- residence in institutions
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ulcerative colitis Endomicroscopy - Crohn's disease Endomicroscopy -
- Primary Outcome Measures
Name Time Method Number of participants with IBD 4 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Erlangen
🇩🇪Erlangen, Germany