MR-based Models for Noninvasive Detection of Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 11
- 主要终点
- Diagnostic Performance of MR-based Models
研究概览
简要总结
Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is invasive and therefore not suitable for routine clinical practice.
This is a multi-center diagnostic trial conducted at high-volume liver centres designed to determine the accuracy of MR-based models (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis. Transjugular 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.
详细描述
Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is invasive and therefore not suitable for routine clinical practice.
This is a multi-center diagnostic trial conducted at high-volume liver centres (Zhongda Hospital, Medical School of Southeast University; Affiliated Lishui Hospital of Zhejiang University; Shandong Provincial Hospital affiliated to Shandong University; Beijing 302 Hospital; Xingtai People's Hospital; Shunde Hospital, Southern Medical University; The First Hospital of Zhengzhou University; Shanghai Public Health Clinical Center, Fudan University; The First Hospital of Lanzhou University; Nanfang Hospital of Southern Medical University; Ankara University School of Medicine) designed to determine the accuracy of MR-based models (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis. Transjugular 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.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •With written informed consent
- •Confirmed liver cirrhosis based on liver biopsy or clinical findings
- •Scheduled to undergo clinically-indicated transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter
- •Has undergone> MR imaging within 14 days to hepatic vein catheterization
- •No hepatic-portal vein interventional therapy between MR imaging and hepatic vein catheterization
排除标准
- •A contraindication to MR imaging, in particular pacemakers or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less than 6 weeks
- •Unable to comply with breathing or other imaging related instructions resulting in inability to obtain diagnostic quality MR imaging studies
- •Contraindication to the injection of contrast agent: pregnancy, lactation, history of allergic reaction to contrast agent injection.
- •Prior transjugular intrahepatic portosystem stent-shunt surgery
- •Prior devascularization operation
- •Has received a liver transplant
- •Any active, serious, life-threatening disease
研究组 & 干预措施
Single arm study
Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol.
干预措施: Transjugular HVPG measurement (Procedure)
Single arm study
Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol.
干预措施: MR imaging (Procedure)
结局指标
主要结局
Diagnostic Performance of MR-based Models
时间窗: 1 day
Accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MR-based models for noninvasive detection of CSPH when compared to HVPG as the reference standard.
次要结局
未报告次要终点
研究者
Xiaolong Qi
Director, Hepatic Hemodynamic Lab
Nanfang Hospital, Southern Medical University