Development and Validation of a Radiomics Signature for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1701): a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 6
- 主要终点
- Diagnostic Accuracy of rHVPG
研究概览
简要总结
This is a prospective, multi-center diagnostic trial conducted at 5 high-volume liver centers in China designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rHVPG) (investigational technology) by CT angiography (CTA) for noninvasive assessment of the clinically significant portal hypertension (CSPH) in patients with 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 diagnostic trial conducted at 5 high-volume liver centers (302 Hospital of PLA; Beijing Shijitan Hospital; The Third Xiangya Hospital of Central South University; Beijing Youan Hospital; Xingtai People's Hospital) in China designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rHVPG) (investigational technology) by CT angiography (CTA) for noninvasive assessment of the clinically significant portal hypertension (CSPH) in patients with 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.
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 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 CT within 14 days prior to hepatic vein catheterization
- •No hepatic-portal vein interventional therapy between the CT 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, HVPG measurement, and rHVPG per protocol. Intervention: Procedure: HVPG measurement
干预措施: HVPG measurement (Procedure)
Single arm study
Patients will receive CTA, HVPG measurement, and rHVPG per protocol. Intervention: Procedure: HVPG measurement
干预措施: CTA (Procedure)
结局指标
主要结局
Diagnostic Accuracy of rHVPG
时间窗: 1 day
Diagnostic accuracy of rHVPG to determine presence or absence of a CSPH when compared to HVPG as the reference standard (HVPG≥10mmHg)
次要结局
- rHVPG Numerical Correlation(1 day)
- Diagnostic Performance of rHVPG(1 day)
研究者
Xiaolong Qi
M.D.
Nanfang Hospital, Southern Medical University