- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00988273
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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Alberta
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Edmonton, Alberta, 캐나다, T6G 2X8
- University of Alberta
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria for patients includes:
- Subjects over 18 years of age.
- Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included.
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Control
In patients undergoing endoscopy for indications other than Crohn's disease or ulcerative colitis
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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.
다른 이름들:
Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.
다른 이름들:
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Diseased group
Patients with Crohn's disease or ulcerative colitis undergoing endoscopy.
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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.
다른 이름들:
Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The intestinal morphology as visualized using confocal laser endomicroscopy
기간: 3 years.
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Intestinal morphology as measured by epithelial cells and gaps, presence of bacteria in the epithelial lining and the lamina propria will be quantitated.
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3 years.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical outcome and pathologic/molecular correlation with intestinal morphology
기간: 3 years.
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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.
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3 years.
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .