Confocal Endomicroscopy During Endoscopy

Study Overview
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Brief Summary
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The main objective of this study is to determine the role of epithelial cell homeostasis in the pathogenesis of intestinal diseases. Background: Alterations in intestinal barrier function may play a significant role in the pathogenesis of chronic intestinal diseases such as inflammatory bowel disease (IBD). The intestinal epithelium functions as a barrier to the luminal contents, thereby preventing undesirable solutes, micro-organisms and other luminal antigens from entering the body. Confocal endomicroscopy has recently been shown that increased epithelial cell shedding may contribute to increased intestinal permeability, at least locally. In our study, we want to determine the contribution of epithelial cell shedding to intestinal permeability in vivo in patients with inflammatory bowel disease compared to controls. Scope: In inflammatory bowel disease patients and controls (patients undergoing endoscopy for other indications). Methods: We will perform confocal endoscopy during the patient's endoscopic procedure. Procedure: The patient will receive intravenous fluorescein, followed by confocal imaging of the gastrointestinal tissue. The images are captured on the computer. The proposed study will provide important insights into epithelial cell shedding as a contributor to altered intestinal permeability.

Official Title
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Confocal Endomicroscopy in Patients Undergoing Endoscopy

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Device: Confocal endomicroscopy
* Device: Confocal endomicroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patients includes: Subjects over 18 years of age. Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included. Exclusion Criteria: Under 18 years of age. Cognitively impaired. Residing in institutions (eg. prison, extended care facility) Employees of research(s)' organization In emergency or life-threatening situations Have language barriers (eg. illiterate, not English-speaking, dysphasic) preventing adequate consent process Resides in another country

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>In patients undergoing endoscopy for indications other than Crohn's disease or ulcerative colitis | Device: Confocal endomicroscopy<br>* Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the control group will be compared to the diseased group.<br>* Other names: laser confocal endomicroscopy;|
| Diseased group<br>Patients with Crohn's disease or ulcerative colitis undergoing endoscopy. | Device: Confocal endomicroscopy<br>* Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.<br>* Other names: laser confocal endomicroscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intestinal morphology as visualized using confocal laser endomicroscopy | Intestinal morphology as measured by epithelial cells and gaps, presence of bacteria in the epithelial lining and the lamina propria will be quantitated. | 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome and pathologic/molecular correlation with intestinal morphology | The clinical outcomes of inflammatory bowel patients, location and severity of their disease, and correlation with molecular studies including tissue cytokine levels will be studied. | 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, Ulcerative colitis, dysplasia