Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Diagnostic Accuracy of vHVPG
研究概览
简要总结
This is a prospective, multi-center trial conducted at 1 Guangzhou and 2 Beijing centers designed to determine the diagnostic performance of virtual hepatic venous pressure gradient (vHVPG) (investigational technology) by anatomic computed tomographic angiography (CTA) for non-invasive assessment of the clinically significant portal hypertension (CSPH) in patients with compensated cirrhosis. Direct hepatic venous pressure gradient (HVPG) measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH, which is defined as HVPG≥10 mmHg.
详细描述
This is a prospective, multi-center trial conducted at 1 Guangzhou (Nanfang Hospital) and 2 Beijing (Beijing 302 Hospital, Beijing Shijitan Hospital) centers designed to determine the diagnostic performance of vHVPG (investigational technology) by anatomic CTA for non-invasive assessment of the CSPH in patients with compensated cirrhosis. Direct HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH, which is defined as HVPG≥10 mmHg.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Patients providing written informed consent
- •Patients with compensated cirrhosis and scheduled to undergo clinically-indicated invasive HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter
- •Has undergone > 64 multi-detector row CTA within 14 days prior to hepatic vein catheterization
- •No hepatic-portal vein interventional therapy between the CTA and hepatic vein catheterization
排除标准
- •Prior transjugular intrahepatic portosystem stent-shunt surgery
- •Prior devascularization operation
- •Has received a liver transplant
- •Patients with known anaphylactic allergy to iodinated contrast
- •Pregnancy or unknown pregnancy status
- •Patient requires an emergent procedure
- •Any active, serious, life-threatening disease
- •Inability to adhere to study procedures
研究组 & 干预措施
Single arm study
Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol.
Intervention: Procedure: HVPG measurement
干预措施: HVPG measurement (Procedure)
Single arm study
Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol.
Intervention: Procedure: HVPG measurement
干预措施: CTA (Procedure)
Single arm study
Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol.
Intervention: Procedure: HVPG measurement
干预措施: Doppler ultrasound (Procedure)
结局指标
主要结局
Diagnostic Accuracy of vHVPG
时间窗: 1 day
Diagnostic accuracy of vHVPG to determine presence or absence of a CSPH when compared to HVPG as the reference standard (HVPG≥10mmHg)
次要结局
- Diagnostic Performance of vHVPG(1 day)
- vHVPG Numerical Correlation(1 day)
研究者
Xiaolong Qi
M.D.
Nanfang Hospital, Southern Medical University