Confocal Endomicroscopy During Endoscopy

University of Alberta

Status: Completed

Conditions: Inflammatory Bowel Disease

Treatments: Device: Confocal endomicroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT00988273

20090821300

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for patients includes:

1. Subjects over 18 years of age.
2. Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included.

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

Trial design

220 participants in 2 patient groups

Control

Description:

In patients undergoing endoscopy for indications other than Crohn's disease or ulcerative colitis

Treatment:

Device: Confocal endomicroscopy

Device: Confocal endomicroscopy

Diseased group

Description:

Patients with Crohn's disease or ulcerative colitis undergoing endoscopy.

Treatment:

Device: Confocal endomicroscopy

Device: Confocal endomicroscopy