Serum Biomarkers Associated With Endothelial Dysfunction and Immune Inflammation for Portal Hypertension in Cirrhosis (Pan-CHESS1802)
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- Correlation between serum biomarkers and HVPG
研究概览
简要总结
This is a prospective, multi-center diagnostic trial conducted at 6 liver centers in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and hepatic venous pressure gradient in cirrhosis.
详细描述
Hepatic venous pressure gradient (HVPG) is the gold standard for assessing portal pressure, of which the measurement is invasive and therefore not suitable for routine clinical practice. The detection of serum biomarkers is potential for noninvasive diagnosis of portal hypertension in cirrhosis. However, many are still in the exploratory phases of testing and are not yet ready to enter clinical practice. This study prospectively enrolled participants in 6 liver centers (Beijing YouAn Hospital, Shandong Provincial Hospital, Beijing Shijitan Hospital, Beijing Friendship Hospital, Xingtai People's Hospital, and 302 Hospital of PLA) in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and HVPG in cirrhosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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;
- •confirmed cirrhosis based on histologic examination of liver or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver.
排除标准
- •prior drug therapy (e.g. β-blocker, vasopressin) within two weeks
- •prior surgeries (e.g. TIPS, partial splenic embolization/ devascularization, splenectomy, liver transplantation)
- •non-sinusoidal portal hypertension & HCC inability to adhere to study procedures
- •pregnancy or unknown pregnancy status
- •no informed consent
结局指标
主要结局
Correlation between serum biomarkers and HVPG
时间窗: 1 day
Correlation between serum biomarkers and HVPG
次要结局
- Correlation between serum biomarkers and HVPG in HBV subgroup(1 day)
研究者
Xiaolong Qi
Director, Hepatic Hemodynamic Lab
Nanfang Hospital, Southern Medical University