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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with known Crohns Disease
- •18 years old or older.
- •Referred to a Magnetic Resonance Imaging scan of the small bowel
排除标准
- •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
结局指标
主要结局
Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging
时间窗: 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
次要结局
- 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(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)
研究者
Rune Wilkens
MD
Regionshospitalet Silkeborg