CLE for Differential Diagnosis of IBD

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Erlangen

Erlangen, 91054, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endomicroscopy

Device

Primary outcomes

Number of participants with IBD

Time frame: 4 years

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2014
First posted: Sep 12, 2014
Registry last updated: Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed