Clinical Trial: Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Confocal Laser Endomicroscopy in Patients With Diarrhea
Brief Summary: The main objective of this study is to determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.
Detailed Summary:
Background:
Diarrhea is characterized by frequent, loose, and watery bowel movements. Common causes include various gastrointestinal infections (e.g. clostridium difficile, salmonella), inflammatory bowel disease (ulcerative colitis, Crohn´s disease), drugs (e.g. antibiotics) and malabsorption syndromes (e.g. celiac and Whipple's disease). Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.
Scope:
In patients with diarrhea.
Methods:
Patients were randomized in two groups. Group 1: Patients underwent standard video colonoscopy for the evaluation of their symptoms. Group 2: During the endoscopic procedure CLE will be performed additionally.
Procedure:
The patient underwent colonoscopy. In Group 2 patients´ will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet during the procedure, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
Sponsor: University of Erlangen-Nürnberg Medical School
Current Primary Outcome: To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy. [ Time Frame: February 2012 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea. [ Time Frame: February 2012 ]
Original Secondary Outcome: Same as current
Information By: University of Erlangen-Nürnberg Medical School
Dates:
Date Received: February 17, 2010
Date Started: February 2010
Date Completion: February 2014
Last Updated: January 23, 2013
Last Verified: January 2013
