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

Haukeland University Hospital

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

Limited In , the inflammation is limited to the large intestine, which includes the rectum. The rest of the gastrointestinal tract is not involved.

Haukeland University HospitalContrast Enhanced Ultrasonography (CEUS) of Patients With Crohn’s Disease

This study is currently recruiting participants.
Verified June 2011 by Haukeland University Hospital

 

First Received on February 23, 2010.   Last Updated on June 27, 2011   History of Changes
Sponsor:Haukeland University Hospital
Collaborators:University of BergenAbbott
Information provided by:Haukeland University Hospital
ClinicalTrials.gov Identifier:NCT01074580

  Purpose

The purpose of this study is investigate if sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn’s disease treated with steroids or TNF alfa inhibitors.

 

Condition
Crohn’s Disease

 

Study Type:Observational
Study Design:Observational Model: CohortTime Perspective: Prospective
Official Title:High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn’s Disease

 

Resource links provided by NLM:

 

 

Further study details as provided by Haukeland University Hospital:

 

Primary Outcome Measures:

  • Remission defined by Crohns disease activity index (CDAI)<150 [ Time Frame: 52 weeks from inclusion ] [ Designated as safety issue: No ]

 

Secondary Outcome Measures:

  • Surgical treatment for Crohn’s disease during follow up. (Surgery for perianal disease not included.) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn’s disease (SES-CD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

from the colon and terminal ileum.

 

Estimated Enrollment:30
Study Start Date:November 2009
Estimated Study Completion Date:November 2012
Estimated Primary Completion Date:November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074580

Contacts
Contact: Kim Nylund, Cand.med.004755973079[email protected]
Contact: Trygve Hausken, PhD004755972134[email protected]

Locations
Norway
Department of Medicine, Haukeland University HospitalRecruiting
Bergen, Hordaland, Norway, 5021
Contact: Kim Nylund, Cand.med.     00475597379     [email protected]
Contact: Trygve Hausken, PhD     004755972134     [email protected]
Principal Investigator: Kim Nylund, Cand.med
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Abbott
Investigators
Study Director:Trygve Hausken, PhDNastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway

  More Information

Additional Information:

No publications provided

Responsible Party:Trygve Hausken, Professor, National Center for Gastroenterological Ultrasonography, Haukeland University Hospital
ClinicalTrials.gov Identifier:NCT01074580     History of Changes
Other Study ID Numbers:22209
Study First Received:February 23, 2010
Last Updated:June 27, 2011
Health Authority:Norway: The National Committees for Research Ethics in Norway

Keywords provided by Haukeland University Hospital:

Crohn’s diseasesonographycontrast enhanced ultrasound

Additional relevant MeSH terms:

Crohn DiseaseInflammatory Bowel DiseasesGastroenteritis

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