Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Confocal Laser Endomicroscopy in Patients With Diarrhea

Conditions
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Diarrhea

Intervention / Treatment
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* Procedure: Colonoscopy
* Procedure: Confocal Laser Endomicroscopy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Patients with diarrhea undergoing endoscopy<br>Standard video colonoscope. | Procedure: Colonoscopy<br>* Patients will undergo colonoscopy for evaluation of their symptoms.<br>|
| Group 2: Patients with diarrhea undergoing endoscopy.<br>Confocal laser endomicroscopy (CLE). | Procedure: Confocal Laser Endomicroscopy<br>* Patients will undergo CLE during their endoscopy. Findings will be compared to group 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea. |  | February 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with diarrhea