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OpenTrials
Completed

NCT Number: NCT00988273

Confocal Endomicroscopy During Endoscopy

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Confocal endomicroscopy

Device

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.

Other names: laser confocal endomicroscopy

Primary outcomes

  1. The intestinal morphology as visualized using confocal laser endomicroscopy

    Time frame: 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 outcomes

  1. Clinical outcome and pathologic/molecular correlation with intestinal morphology

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Confocal Endomicroscopy in Patients Undergoing Endoscopy

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 2, 2009
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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