A Comparative Study of Capsule Endoscopy, Magnetic Resonance Imaging and Computer Tomography Scanning of the Small Bowel in Crohn's Disease

NCT01019460 | Completed DMC

• 1 other identifier: S-20070072
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn's Disease

Keywords

Small intestine; Magnetic resonance imaging; Computed tomography scanning; Capsule endoscopy

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity for CT scanning of the small bowel, MRI of the small bowel and CE.

  February 2010

Secondary Outcomes (1)

• Interobserver variation for capsule endoscopy, MRI and CT scanning of the small intestine Patient experienced discomfort

  February 2010

Interventions

Magnetic resonance imaging, computed tomography scanning and capsule endoscopy PROCEDURE

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.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Acute bowel obstruction, elevated serum-creatinine, severe claustrophobia, cardiac pacemaker, implanted magnetic foreign bodies, use of NSAID's, pregnancy and lactation

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator

Related Publications (2)

• Jensen MD, Andersen RF, Christensen H, Nathan T, Kjeldsen J, Madsen JS. Circulating microRNAs as biomarkers of adult Crohn's disease. Eur J Gastroenterol Hepatol. 2015 Sep;27(9):1038-44. doi: 10.1097/MEG.0000000000000430.

  PMID: 26230660 DERIVED

• Jensen MD, Nathan T, Rafaelsen SR, Kjeldsen J. Ileoscopy reduces the need for small bowel imaging in suspected Crohn's disease. Dan Med J. 2012 Sep;59(9):A4491.

  PMID: 22951194 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: October 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: August 1, 2011
• Last Updated: September 21, 2011

Record last verified: 2011-09