ClinicalTrials.gov
ClinicalTrials.gov Menu

Confocal Endomicroscopy During Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00988273
Recruitment Status : Unknown
Verified April 2012 by Julia Liu, University of Alberta.
Recruitment status was:  Recruiting
First Posted : October 2, 2009
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):
Julia Liu, 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.


Condition or disease Intervention/treatment
Inflammatory Bowel Disease Device: Confocal endomicroscopy

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Confocal Endomicroscopy in Patients Undergoing Endoscopy
Study Start Date : October 2009
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
Control
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Biopsy samples


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988273


Contacts
Contact: Julia J. Liu, MD 780-492-7062 julia.liu@ualberta.ca
Contact: Richard N. Fedorak, MD 780 492-6941 Richard.Fedorak@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Contact: Julia J Liu, MD    780-492-7062    julia.liu@ualberta.ca   
Principal Investigator: Julia J Liu, MD         
Sponsors and Collaborators
University of Alberta

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julia Liu, Dr. Julia Liu, University of Alberta
ClinicalTrials.gov Identifier: NCT00988273     History of Changes
Other Study ID Numbers: 20090821300
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases