NCT01072110

Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea

Confocal Laser Endomicroscopy in Patients With Diarrhea

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Diarrhea

Interventions

Type	Name	Description
PROCEDURE	Colonoscopy	Patients will undergo colonoscopy for evaluation of their symptoms.
PROCEDURE	Confocal Laser Endomicroscopy	Patients will undergo CLE during their endoscopy. Findings will be compared to group 1.

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-01-01
• Completion: 2014-02-01
• First posted: 2010-02-19
• Last updated: 2020-12-14

Locations

1 site across 1 country: Germany