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Confocal Endomicroscopy During Endoscopy

Confocal Endomicroscopy in Patients Undergoing Endoscopy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00988273
Enrollment
220
Registered
2009-10-02
Start date
2009-10-31
Completion date
2014-12-31
Last updated
2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

Crohn's disease, Ulcerative colitis, dysplasia

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.

Interventions

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.

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The intestinal morphology as visualized using confocal laser endomicroscopy3 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

MeasureTime frameDescription
Clinical outcome and pathologic/molecular correlation with intestinal morphology3 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026