Confocal Endomicroscopy During Endoscopy

NCT00988273 | Completed

• 1 other identifier: 20090821300
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

Crohn's disease; Ulcerative colitis; dysplasia

Outcome Measures

Primary Outcomes (1)

• The intestinal morphology as visualized using confocal laser endomicroscopy

  Intestinal morphology as measured by epithelial cells and gaps, presence of bacteria in the epithelial lining and the lamina propria will be quantitated.

  3 years.

Secondary Outcomes (1)

• Clinical outcome and pathologic/molecular correlation with intestinal morphology

  3 years.

Study Arms (2)

Control

In patients undergoing endoscopy for indications other than Crohn's disease or ulcerative colitis

Device: Confocal endomicroscopy

Diseased group

Patients with Crohn's disease or ulcerative colitis undergoing endoscopy.

Device: Confocal endomicroscopy

Interventions

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.

Also known as: laser confocal endomicroscopy

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects over 18 years of age.
• Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

Location

Related Publications (4)

• 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.

  PMID: 21396639 BACKGROUND

• Turcotte JF, Wong K, Mah SJ, Dieleman LA, Kao D, Kroeker K, Claggett B, Saltzman JR, Wine E, Fedorak RN, Liu JJ. Increased epithelial gaps in the small intestine are predictive of hospitalization and surgery in patients with inflammatory bowel disease. Clin Transl Gastroenterol. 2012 Jul 26;3(7):e19. doi: 10.1038/ctg.2012.13.

  PMID: 23238291 BACKGROUND

• Liu JJ, Davis EM, Wine E, Lou Y, Rudzinski JK, Alipour M, Boulanger P, Thiesen AL, Sergi C, Fedorak RN, Muruve D, Madsen KL, Irvin RT. Epithelial cell extrusion leads to breaches in the intestinal epithelium. Inflamm Bowel Dis. 2013 Apr;19(5):912-21. doi: 10.1097/MIB.0b013e3182807600.

  PMID: 23511029 BACKGROUND

• Turcotte JF, Kao D, Mah SJ, Claggett B, Saltzman JR, Fedorak RN, Liu JJ. Breaks in the wall: increased gaps in the intestinal epithelium of irritable bowel syndrome patients identified by confocal laser endomicroscopy (with videos). Gastrointest Endosc. 2013 Apr;77(4):624-30. doi: 10.1016/j.gie.2012.11.006. Epub 2013 Jan 26.

  PMID: 23357497 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 16, 2018

Record last verified: 2012-04

Locations

CA (1)