- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
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Alberta
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Edmonton, Alberta, Canada, T6G 2X8
- University of Alberta
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Control
In patients undergoing endoscopy for indications other than Crohn's disease or ulcerative colitis
|
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.
Autres noms:
Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.
Autres noms:
|
Diseased group
Patients with Crohn's disease or ulcerative colitis undergoing endoscopy.
|
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.
Autres noms:
Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The intestinal morphology as visualized using confocal laser endomicroscopy
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Clinical outcome and pathologic/molecular correlation with intestinal morphology
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20090821300
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