Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease (KULT)

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)

The purpose of this study is to determine how relevant dynamic ultrasound scans using contrast agents (SonoVue) is in the diagnosis of Crohns disease in the small bowel, compared to dynamic Magnetic Resonance Imaging (MRI) of the small bowel.

Study Overview

• Status: Completed
• Conditions: Crohn Disease

Detailed Description

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
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, DK-8000
    • Aarhus University Hospital
  • Silkeborg, Denmark, DK-8600
    • Medical department, Regional Hospital of Silkeborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated on Regional Hospital of Silkeborg.

Description

Inclusion Criteria:

• Patients with known Crohns Disease
• 18 years old or older.
• Referred to a Magnetic Resonance Imaging scan of the small bowel

Exclusion Criteria:

• Contraindications to or not suitable of a Magnetic Resonance Imaging
• Liver transplant
• nursing og pregnancy
• Known Allergy of SonoVue
• Acute Myocardial infarction < 4 weeks
• Coronary angiography < 4 weeks
• Electrocardiogram changes < 4 weeks
• frequent and repetitive angina pectoris symptoms within the last week.
• Heartfailure
• serious arrhythmia
• right to left heart shunt
• Very high pulmonary artery pressure
• uncontrolled hypertension
• Adult respiratory distress syndrome

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Crohn Disease; Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging	Time intesity curves are obtained using intra venous contrast agents during Magnetic Resonance Imaging scans and Ultrasound examination of the small bowel	up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel		up to 1 week
Correlation between Doppler Score and Contrast Enhanced Ultrasound Score	Doppler score (Limberg score) and Contrast Enhanced Ultrasound score are obtained during the same scanning procedure	up to 1 week
Correlation between greatest bowel wall thickness and disease activity measured in Ultrasound and Magnetic Resonance Imaging		up to 1 week
Correlation between Ultrasound score and Faeces Calprotectin		up to 2 months
Correlation between Crohns disease activity index and Ultrasound score		up to 2 months

Collaborators and Investigators

• Sponsor: Rune Wilkens
• Investigators: Study Chair: Henning Glerup, Region Hospital of Silkeborg; Principal Investigator: Rune Wilkens, Region Hospital of Silkeborg; Principal Investigator: Lars B. Hansen, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): July 16, 2013
• Last Update Submitted That Met QC Criteria: July 15, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; IBD; Crohn disease; Sonography; Calprotectin; CDAI; Elasticity Imaging Techniques; Small intestine; Ultrasonography, contrast enhanced
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: HGRWLBKULT1; 2010-024528-12 (EudraCT Number)