Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)
研究概览
简要总结
The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type of ultrasound) in assessing the pressure of the portal vein (the major vein passing through the liver) and the amount of liver fibrosis in patients with chronic liver disease.
详细描述
DESIGN The study is designed as a prospective, cross-sectional, diagnostic study in which the investigators will evaluate the use of ARFI to diagnose clinically significant portal hypertension (CSPH defined as hepatic veous pressure gradient (HVPG)greater than 10 mmHg), taking HVPG measurements as gold standard.
METHODOLOGY
- The study will be performed at the VA Connecticut Healthcare System-West Haven and Yale.
- Study population will be recruited among patients from the VA/Yale Liver Clinics or outside hospitals that are referred to VA/Yale for a transjugular liver biopsy and hepatic venous pressure gradient measurement as part of their routine care.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-85 years
- •compensated chronic liver disease with suspected or confirmed liver cirrhosis sent for transjugular liver biopsy as part of their routine care
- •signed informed consent
排除标准
- •known contraindications to the performance of an HVPG measurement or a trans-jugular biopsy
- •portal thrombosis
- •previous surgical or transjugular portosystemic shunt
- •previous total or partial splenectomy
- •presence of comorbid conditions conferring a life expectancy of less than 1 year
研究组 & 干预措施
acoustic radiation force impulse (ARFI)
Imaging of liver and spleen using modified ultrasound
干预措施: ARFI ultrasound (Device)
结局指标
主要结局
correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)
时间窗: Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours
Both measurements are estimates of portal hypertension (defined as equal to HVPG greater than 10 mmHg).
次要结局
未报告次要终点