Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Correlation between contrast-enhanced ultrasound time-intensity curves and endoscopic disease activity
研究概览
简要总结
The purpose of this study is to determine the efficacy of SonoVue® in participants with Crohn's disease and ulcerative colitis to various aspects including type of Inflammatory Bowel Disease, disease activity, the need for surgical treatment.
详细描述
Each patient is subjected to clinical, laboratory and endoscopic evaluation, each eligible patient is assigned to one of the arms:
Arm 1: patients with ulcerative colitis (50 patients) Arm 2: patients with Crohn's disease (50 patients) In each arm, patients are classified according to clinical an endoscopic activity of the disease.
Each patient is subjected to ultrasound examination of the bowel using a Philips iU 22 machine according to a standardized protocol:
- 12h fasting period
- exploratory scanning with the use of convex C5-1 probe
- detailed scanning with the use of linear L 12-5 probe with Power Doppler
- choosing a bowel segment with the most prominent changes
- Contrast-enhanced Ultrasound (CEUS)
CEUS is performed according to the following protocol:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with verified UC/CD aged from 18 to 60y
- •signed informed consent form for the study
排除标准
- •pregnancy
- •known allergy or history of adverse reaction to sulfur hexafluoride preparations
- •marked pulmonary hypertension
- •uncontrolled hypertension
研究组 & 干预措施
patients with UC
Patients with endoscopically proven UC with various extents of disease activity.
Diagnostic Test: Contrast-enhanced Ultrasound
干预措施: Contrast-enhanced Ultrasound (Diagnostic Test)
patients with CD
Patients with proven CD with various extents of disease activity Diagnostic Test: Contrast-enhanced Ultrasound
干预措施: Contrast-enhanced Ultrasound (Diagnostic Test)
结局指标
主要结局
Correlation between contrast-enhanced ultrasound time-intensity curves and endoscopic disease activity
时间窗: [7 days]
Particular time-intensity curve characteristics (AUC, Peak intensity etc.) could correlate with endoscopic activity of ulcerative colitis
次要结局
- Correlation between contrast-enhanced ultrasound time-intensity curves in patients with Crohn disease and fibrosis grade according to morphologic analysis of the resected bowel segment([14 days])