Confocal Endomicroscopy During Endoscopy

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Device: Confocal endomicroscopy

• Registration Number: NCT00988273
• Lead Sponsor: University of Alberta

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Status Verified: 2012-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

1. Under 18 years of age.
2. Cognitively impaired.
3. Residing in institutions (eg. prison, extended care facility)
4. Employees of research(s)' organization
5. In emergency or life-threatening situations
6. Have language barriers (eg. illiterate, not English-speaking, dysphasic) preventing adequate consent process
7. Resides in another country

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Confocal endomicroscopy	In patients undergoing endoscopy for indications other than Crohn's disease or ulcerative colitis
Diseased group	Confocal endomicroscopy	Patients with Crohn's disease or ulcerative colitis undergoing endoscopy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical outcome and pathologic/molecular correlation with intestinal morphology	3 years.	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.

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada