Text Size

Confocal Endomicroscopy During Endoscopy

This study is currently recruiting participants.
Verified April 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Julia Liu, University of Alberta
ClinicalTrials.gov Identifier:
NCT00988273
First received: October 1, 2009
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  Purpose

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 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:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • The intestinal morphology as visualized using confocal laser endomicroscopy [ Time Frame: 3 years. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of Alberta

Additional 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
Study First Received: October 1, 2009
Last Updated: April 27, 2012
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on May 19, 2013