Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease (KULT)
|ClinicalTrials.gov Identifier: NCT01365767|
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : July 16, 2013
|Condition or disease|
Crohns disease (CD) is a lifelong chronic Inflammatory Bowel Disease (IBD) normally with an early debut. It requires continuous evaluation with either endoscopy, Magnetic Resonance Imaging (MRI), Computed Tomography (CT) or Wireless Capsule Endoscopy (WCE). These methods are either expensive, invasive or with uses radiation. Therefore UltraSound (US), as a cheap, fast and well tolerated examination of the small bowel are tested against the the validated MRI examination of the small bowel. Both examinations are using intra venous (i.v.) contrast agents. Obtained results are compared to disease activity.
Hypothesis is, that dynamic US is comparable to dynamic MRI and therefore should be the first examination of choice in evaluating patients with CD.
This study is a pilot study only.
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Kontrast UltraLydsskanning af Tyndtarmen Hos Patienter Med Crohns Sygdom - et Pilotstudie. (Danish) Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease - a Pilot Study (English)|
|Study Start Date :||May 2011|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan.
- Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging [ Time Frame: up to 1 week ]Time intesity curves are obtained using intra venous contrast agents during Magnetic Resonance Imaging scans and Ultrasound examination of the small bowel
- Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel [ Time Frame: up to 1 week ]
- Correlation between Doppler Score and Contrast Enhanced Ultrasound Score [ Time Frame: up to 1 week ]Doppler score (Limberg score) and Contrast Enhanced Ultrasound score are obtained during the same scanning procedure
- Correlation between greatest bowel wall thickness and disease activity measured in Ultrasound and Magnetic Resonance Imaging [ Time Frame: up to 1 week ]
- Correlation between Ultrasound score and Faeces Calprotectin [ Time Frame: up to 2 months ]
- Correlation between Crohns disease activity index and Ultrasound score [ Time Frame: up to 2 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365767
|Aarhus University Hospital|
|Aarhus, Denmark, DK-8000|
|Medical department, Regional Hospital of Silkeborg|
|Silkeborg, Denmark, DK-8600|
|Study Chair:||Henning Glerup||Region Hospital of Silkeborg|
|Principal Investigator:||Rune Wilkens||Region Hospital of Silkeborg|
|Principal Investigator:||Lars B. Hansen||Aarhus University Hospital|