CLE for Differential Diagnosis of IBD

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: Inflammatory Bowel Diseases

Treatments: Device: Endomicroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT02238665

HN-0005

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

105 participants in 2 patient groups

Ulcerative colitis

Treatment:

Device: Endomicroscopy

Crohn's disease

Treatment:

Device: Endomicroscopy