Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea

Completed

• Conditions: Diarrhea
• Interventions: Procedure: Colonoscopy; Procedure: Confocal Laser Endomicroscopy

• Registration Number: NCT01072110
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Written informed consent
• Age 18-85 years
• Ability of subjects to understand character and individual consequences of clinical trial
• Subjects undergoing colonoscopy

Exclusion Criteria

• Inability to provide written informed consent
• Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
• Impaired renal function (Creatinine > 1.2 mg/dl)
• Pregnancy or breast feeding
• Active gastrointestinal bleeding
• Known allergy to fluorescein, acriflavin or cresyl violet
• Residing in institutions (e.g. prison)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: Patients with diarrhea undergoing endoscopy	Colonoscopy	Standard video colonoscope.
Group 2: Patients with diarrhea undergoing endoscopy.	Confocal Laser Endomicroscopy	Confocal laser endomicroscopy (CLE).

Primary Outcome Measures

Name	Time	Method
To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.	February 2012

Secondary Outcome Measures

Name	Time	Method
To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea.	February 2012