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Contrast Enhanced Ultrasonography (CEUS) of Patients With Crohn's Disease

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ClinicalTrials.gov Identifier: NCT01074580
Recruitment Status : Terminated (Did not get enough patients)
First Posted : February 24, 2010
Last Update Posted : January 26, 2016
Sponsor:
Collaborators:
University of Bergen
Abbott
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
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Brief Summary:
The purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.

Condition or disease
Crohn's Disease

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease
Study Start Date : November 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Deterioration, Crohn's disease
Patients > 18 years old with a deterioration of Crohn's disease defined by CDAI >150 and requiring treatment with systemic steroids or TNF alfa inhibitors


Outcome Measures
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Primary Outcome Measures :
  1. Remission defined by Crohns disease activity index (CDAI)<150 [ Time Frame: 52 weeks from inclusion ]

Secondary Outcome Measures :
  1. Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.) [ Time Frame: 52 weeks ]
  2. Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD) [ Time Frame: 12 weeks ]

Biospecimen Retention:   Samples With DNA
Mucosal biopsies from the colon and terminal ileum.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated for deterioration of Crohn's disease either in the out patient clinic or the medical ward of Haukeland University Hospital.
Criteria

Inclusion Criteria:

  • Deterioration of Crohn's disease
  • CDAI>150
  • Treated with systemic steroids or TNF alfa inhibitors
  • Lesion found on ultrasound

Exclusion Criteria:

  • Disease location not reachable with ileocolonoscopy
  • Pregnancy
  • Acute coronary disease
  • Unstable coronary disease
  • Previous allergic reaction to SonoVue or its components
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074580


Locations
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Norway
Department of Medicine, Haukeland University Hospital
Bergen, Hordaland, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Abbott
Investigators
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Study Director: Trygve Hausken, PhD Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway
More Information
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01074580    
Other Study ID Numbers: 22209
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Keywords provided by Haukeland University Hospital:
Crohn's disease
sonography
contrast enhanced ultrasound
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases