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 |
Recruitment Status
:
Completed
First Posted
: November 25, 2009
Last Update Posted
: September 21, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Procedure: Magnetic resonance imaging, computed tomography scanning and capsule endoscopy | Not Applicable |

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 |

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Procedure: Magnetic resonance imaging, computed tomography scanning and capsule endoscopy
- Sensitivity and specificity for CT scanning of the small bowel, MRI of the small bowel and CE. [ Time Frame: February 2010 ]
- 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 |
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
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:
Small intestine Magnetic resonance imaging Computed tomography scanning Capsule endoscopy |
Additional relevant MeSH terms:
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |