Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea
Recruitment status was: Recruiting
|Study Design:||Time Perspective: Prospective|
|Official Title:||Confocal Laser Endomicroscopy in Patients With Diarrhea|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Group 1: Patients with diarrhea undergoing endoscopy
Standard video colonoscope.
Patients will undergo colonoscopy for evaluation of their symptoms.
Group 2: Patients with diarrhea undergoing endoscopy.
Confocal laser endomicroscopy (CLE).
Procedure: Confocal Laser Endomicroscopy
Patients will undergo CLE during their endoscopy. Findings will be compared to group 1.
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.
In patients with diarrhea.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072110
|Erlangen, Germany, 91054|
|Principal Investigator:||Markus F. Neurath, M.D., Ph.D.||Department of Medicine I, University of Erlangen-Nuremberg|