High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease

Haukeland University Hospital1 site in 1 country20 target enrollmentNovember 2009

ConditionsCrohn's Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Crohn's Disease
Sponsor: Haukeland University Hospital
Enrollment: 20
Locations: 1
Primary Endpoint: Remission defined by Crohns disease activity index (CDAI)<150
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

December 2013

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Haukeland University Hospital

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Remission defined by Crohns disease activity index (CDAI)<150

Time Frame: 52 weeks from inclusion

Secondary Outcomes

Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD)(12 weeks)
Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.)(52 weeks)