Confocal Endomicroscopy During Endoscopy

NCT ID: NCT00988273

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

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

Confocal endomicroscopy

Intervention Type 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.

Diseased group

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

Confocal endomicroscopy

Intervention Type DEVICE

Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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laser confocal endomicroscopy laser confocal endomicroscopy

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 21396639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23238291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23511029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23357497 (View on PubMed)

Other Identifiers

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20090821300

Identifier Type: -

Identifier Source: org_study_id

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