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

September 20, 2011 updated by: Michael Dam Jensen, University of Southern Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OVERALL AIM OF THE STUDY To evaluate three diagnostic methods for assessment of intestinal disease in patients with suspected or newly diagnosed Crohn's disease and patients with known Crohn's disease.

PARTICIPATING CENTRES

  • Department of Medical Gastroenterology, Odense University Hospital, DK-5000 Odense C
  • Department of Internal Medicine, section of Gastroenterology, Vejle Hospital, DK-7100 Vejle
  • Department of Internal Medicine, section of Gastroenterology, Sydvestjysk Hospital, DK-6700 Esbjerg
  • Department of Internal Medicine, section of Gastroenterology, Svendborg Hospital, DK-5700 Svendborg
  • Department of Radiology, Vejle Hospital, DK-7100 Vejle

PROTOCOL A

A comparative study of capsule endoscopy, magnetic resonance imaging and computer tomography scanning of the small bowel in patients with suspected or newly diagnosed Crohn's disease

Protocol procedures:

At inclusion all patients will have a standardised work-up including medical history, physical examination, blood and faeces samples and ileo-colonoscopy. Within two weeks MRI and CT scanning of the small intestine (on the same day and in randomised order) and subsequently CE will be performed in all patients. 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 CE are blinded to the findings at ileo-colonoscopy and the other small bowel examinations. In the follow-up part of the study the physician in charge of the patient will be randomised to receive the results of either MRI, CT or CE.

Anticipated outcome:

The study is performed to improve evidence about what is the best primary investigation for assessment of small intestinal involvement in patients with suspected Crohn's disease, to evaluate if a combination of diagnostic modalities may improve our assessment of disease burden for the individual patients, to study whether the initial diagnostic modalities affect the handling of the patients and to study the interobserver variation of MRI and CT scanning.

PROTOCOL B

A comparative study of magnetic resonance imaging, computer tomography scanning and capsule endoscopy in patients with known Crohn's disease

Protocol procedures:

At inclusion all patients will undergo a standardised work-up including history, physical examination, blood and faeces samples and ileo-colonoscopy. Within two weeks MRI, CT scanning of the small intestine (on the same day in randomised order) and capsule endoscopy will be performed in all patients. Capsule endoscopy will not be performed in patients with small bowel stenosis confirmed at ileo-colonoscopy, MRI and/or CT. All three investigations will be described in a similar predefined standardized fashion with the radiologist blinded to the findings at ileo-colonoscopy. In the randomised part of the study the physician in charge of the patient will be randomised to receive the result of either MRI, CT og capsule endoscopy.

Anticipated outcome:

The best diagnostic method for evaluation of small intestinal involvement in patients with known Crohn's disease may be different from patients suspected of Crohn's disease. Thus in the current study we hope to provide evidence of whether MRI, CT scanning or capsule endoscopy is the best diagnostic approach.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity for CT scanning of the small bowel, MRI of the small bowel and CE.
Time Frame: February 2010
February 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Interobserver variation for capsule endoscopy, MRI and CT scanning of the small intestine Patient experienced discomfort
Time Frame: February 2010
February 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (ESTIMATE)

November 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20070072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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