A Comparative Study of Capsule Endoscopy, Magnetic Resonance Imaging and Computer Tomography Scanning of the Small Bowel in Crohn's Disease
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| ClinicalTrials.gov Identifier: NCT01019460 |
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Recruitment Status
:
Completed
First Posted
: November 25, 2009
Last Update Posted
: September 21, 2011
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Sponsor:
University of Southern Denmark
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Michael Dam Jensen, University of Southern Denmark
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Crohn's Disease | Procedure: Magnetic resonance imaging, computed tomography scanning and capsule endoscopy | Not Applicable |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 150 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | Double (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 |
| Study Start Date : | October 2007 |
| Actual Primary Completion Date : | October 2010 |
| Actual Study Completion Date : | August 2011 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
CT Scans
Crohn's Disease
Diagnostic Imaging
Endoscopy
MRI Scans
Nuclear Scans
U.S. FDA Resources
Intervention Details:
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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.
Primary Outcome Measures
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- Sensitivity and specificity for CT scanning of the small bowel, MRI of the small bowel and CE. [ Time Frame: February 2010 ]
Secondary Outcome Measures
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- Interobserver variation for capsule endoscopy, MRI and CT scanning of the small intestine Patient experienced discomfort [ Time Frame: February 2010 ]
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| Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
General criteria:
- Age > 15 years
- Written informed consent
Patients with established CD are included if assessment of small bowel disease was necessary prior to expected surgery or a change in medical therapy.
Patients with suspected CD are included on either clinical, endoscopical or histological criteria or a combination of these.
- Clinical criteria: Diarrhoea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhoea and/or abdominal pain) associated with one or more of the following findings: CRP > 5 mg/l, thrombocytosis, anaemia, fever, weight loss, perianal abscess/fistula or a family history of inflammatory bowel disease.
- Endoscopical criteria (at least one): Ulcerations and/or stenosis in the terminal ileum, inflammation in the colon not involving the rectum, and aphthous ulcerations in the colon.
- Histological criteria (at least one): Epitheloid cell granulomas, chronic inflammation in the lamina muscularis mucosae or deeper and chronic inflammation in the colon not involving the rectum.
Exclusion Criteria:
- Acute bowel obstruction, elevated serum-creatinine, severe claustrophobia, cardiac pacemaker, implanted magnetic foreign bodies, use of NSAID's, pregnancy and lactation
No Contacts or Locations Provided
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael Dam Jensen, Dr, University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT01019460 History of Changes |
| Other Study ID Numbers: |
S-20070072 |
| First Posted: | November 25, 2009 Key Record Dates |
| Last Update Posted: | September 21, 2011 |
| Last Verified: | September 2011 |
Keywords provided by Michael Dam Jensen, University of Southern Denmark:
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Small intestine Magnetic resonance imaging Computed tomography scanning Capsule endoscopy |
Additional relevant MeSH terms:
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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |