A Comparative Study of Capsule Endoscopy, Magnetic Resonance Imaging and Computer Tomography Scanning of the Small Bowel in Crohn's Disease
This study has been completed.
University of Southern Denmark
Odense University Hospital
Information provided by (Responsible Party):
Michael Dam Jensen, University of Southern Denmark
First received: November 24, 2009
Last updated: September 20, 2011
Last verified: September 2011
The aim of this study is to evaluate three diagnostic methods for assessing small bowel disease in patients with suspected or known Crohn's disease. All patients are examined with ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. However, capsule endoscopy is not performed in patients with stenosis detected at ileo-colonoscopy, MRI and/or CT. All investigations are described in a similar pre-defined and standardized fashion and the radiologist and physician responsible for describing the findings at MRI, CT and capsule endoscopy are blinded to the findings at ileo-colonoscopy. The physician in charge of treatment receives a randomised result of either MRI, CT or capsule endoscopy. Thereafter patients are followed during 12 months to evaluate differences in clinical outcome depending on the randomized result. In combination with the diagnostic validity and inter-observer agreement of MRI, CT and capsule endoscopy we seek to establish the optimal diagnostic strategy in these two patient categories.
|Crohn's Disease||Procedure: Magnetic resonance imaging, computed tomography scanning and capsule endoscopy|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Diagnostic
|Official Title:||A Comparative Study of Capsule Endoscopy, Magnetic Resonance Imaging and Computer Tomography Scanning of the Small Bowel in Crohn's Disease|
Resource links provided by NLM:
MedlinePlus related topics: CT Scans Crohn's Disease Diagnostic Imaging Endoscopy MRI Scans Nuclear ScansU.S. FDA Resources
Further study details as provided by Michael Dam Jensen, University of Southern Denmark:
Primary Outcome Measures:
- Sensitivity and specificity for CT scanning of the small bowel, MRI of the small bowel and CE. [ Time Frame: February 2010 ]
Secondary Outcome Measures:
- Interobserver variation for capsule endoscopy, MRI and CT scanning of the small intestine Patient experienced discomfort [ Time Frame: February 2010 ]
|Study Start Date:||October 2007|
|Study Completion Date:||August 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Intervention Details:Show Detailed Description
Procedure: Magnetic resonance imaging, computed tomography scanning and capsule endoscopy
All patients are examined with ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. Capsule endoscopy will not be performed in patients with small bowel stenosis confirmed at ileo-colonoscopy, MRI and/or CT.
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