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Confocal Endomicroscopy During Endoscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Julia Liu, University of Alberta.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Julia Liu, University of Alberta Identifier:
First received: October 1, 2009
Last updated: April 27, 2012
Last verified: April 2012

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.


In inflammatory bowel disease patients and controls (patients undergoing endoscopy for other indications).


We will perform confocal endoscopy during the patient's endoscopic 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.

Condition Intervention Phase
Inflammatory Bowel Disease
Device: Confocal endomicroscopy
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Confocal Endomicroscopy in Patients Undergoing Endoscopy

Resource links provided by NLM:

Further study details as provided by Julia Liu, University of Alberta:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Biospecimen Retention:   Samples Without DNA
Biopsy samples

Estimated Enrollment: 400
Study Start Date: October 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
In patients undergoing endoscopy for indications other than Crohn's disease or ulcerative colitis
Device: Confocal endomicroscopy
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 Name: laser confocal endomicroscopy
Diseased group
Patients with Crohn's disease or ulcerative colitis undergoing endoscopy.
Device: Confocal endomicroscopy
Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.
Other Name: laser confocal endomicroscopy


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing endoscopy: study group are patients evaluated for IBD symptoms and control patients for other indications such as colon cancer screening, positive fecal occult testing, constipation or diarrhea.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00988273

Contact: Julia J. Liu, MD 780-492-7062
Contact: Richard N. Fedorak, MD 780 492-6941

Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Contact: Julia J Liu, MD    780-492-7062   
Principal Investigator: Julia J Liu, MD         
Sponsors and Collaborators
University of Alberta
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Julia Liu, Dr. Julia Liu, University of Alberta Identifier: NCT00988273     History of Changes
Other Study ID Numbers: 20090821300
Study First Received: October 1, 2009
Last Updated: April 27, 2012

Keywords provided by Julia Liu, University of Alberta:
Crohn's disease
Ulcerative colitis

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on May 25, 2017