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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
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Michael Dam Jensen, University of Southern Denmark

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

U.S. FDA Resources


Intervention Details:
    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 :
  1. Sensitivity and specificity for CT scanning of the small bowel, MRI of the small bowel and CE. [ Time Frame: February 2010 ]

Secondary Outcome Measures :
  1. 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

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