Noninvasive Detection of Liver Injury Immediately Following the Fontan Operation: the Role of Ultrasound-Based Elastography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Shear Wave Speed (Liver Stiffness)
研究概览
简要总结
The purpose of this study is to compare the liver stiffness, which can be caused by congestion and fibrosis in pediatric patients before and after a Fontan heart operation.
A new form of ultrasound elastography (Acoustic Radiation Force Impulse, or ARFI) will measure liver stiffness.
详细描述
The Fontan repair for single ventricle congenital heart lesions consists of three stages. This surgery has enable pediatric patients who have the repair to live into adulthood.
Stage 3 of the surgery introduces immediate congestion of blood in the liver by increasing central venous pressure (CVP). CVP is the blood pressure within the vena cava, a major blood vessel in the body.
Many patients later develop progressive liver fibrosis (stiffness) possibly as a result of increased blood pressure. Liver stiffness is increased both by congestion and fibrosis.
Liver fibrosis has significant health risks and may complicate the patient's future healthcare.
There are no established, noninvasive means of detecting the liver fibrosis until it becomes severe. Acoustic radiation force impulse (ARFI) elastography, an ultrasound technique, can measure the stiffness of the liver safely from outside the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients ages 0-17
- •Patients presenting to the University of Michigan for evaluation just before undergoing stage 3 of the Fontan operation
排除标准
- •Patients over the age of 17
- •Patients who have chronic liver disease (elevation of ALT, AST, or Bilirubin greater than two times the upper limits of normal >4 weeks)
- •Patients who have evidence of liver enlargement or nodularity on prior ultrasound imaging
- •Patients who have a history of portal vein or hepatic vein thrombosis
- •Patients (parents) who are unwilling to read and sign the informed consent document
结局指标
主要结局
Shear Wave Speed (Liver Stiffness)
时间窗: 0-6 months
ARFI shear wave speed measurements were done on the right lobe of the liver. Measurement units are m/s (meters per second). A total of 8 measurements were performed on each subject at each time point.The 8 values were performed on each subject and averaged.
次要结局
- IVC Pressure(Baseline and Follow Up Number 1 (approximately 24 -72 hours later))
研究者
Frank Dipaola
Principal Investigator
University of Michigan