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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

This study has been completed.
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Michael Dam Jensen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01019460
First received: November 24, 2009
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  Purpose
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 Intervention
Crohn's Disease
 Procedure: Magnetic resonance imaging, computed tomography scanning and capsule endoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interobserver variation for capsule endoscopy, MRI and CT scanning of the small intestine Patient experienced discomfort [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
Enrollment: 150
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:
    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.
  Show Detailed Description

  Eligibility
Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

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 
Study First Received: November 24, 2009
Last Updated: September 20, 2011
Health Authority: Denmark: Local Ethics Committee of Southern Denmark
Denmark: Danish Data Protection Agency

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016