Confocal Endomicroscopy During Endoscopy

This study is currently recruiting participants. (see Contacts and Locations)
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

October 1, 2009
April 27, 2012
October 2009
December 2014   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00988273 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Confocal Endomicroscopy During Endoscopy
Confocal Endomicroscopy in Patients Undergoing 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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Biopsy samples

Non-Probability Sample

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.

Inflammatory Bowel Disease
  • 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
  • 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
  • Control
    In patients undergoing endoscopy for indications other than Crohn's disease or ulcerative colitis
    Intervention: Device: Confocal endomicroscopy
  • Diseased group
    Patients with Crohn's disease or ulcerative colitis undergoing endoscopy.
    Intervention: Device: Confocal endomicroscopy
Liu JJ, Wong K, Thiesen AL, Mah SJ, Dieleman LA, Claggett B, Saltzman JR, Fedorak RN. Increased epithelial gaps in the small intestines of patients with inflammatory bowel disease: density matters. Gastrointest Endosc. 2011 Jun;73(6):1174-80. doi: 10.1016/j.gie.2011.01.018. Epub 2011 Mar 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact: Julia J. Liu, MD 780-492-7062 julia.liu@ualberta.ca
Contact: Richard N. Fedorak, MD 780 492-6941 Richard.Fedorak@ualberta.ca
Canada
 
NCT00988273
20090821300
No
Julia Liu, University of Alberta
University of Alberta
Not Provided
Not Provided
University of Alberta
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP