Study on the Measurement of Portal Vein Pressure Gradient Guided by Endoscopic Ultrasound Based on Portal Vein Thrombosis and Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 主要终点
- Mean Portal Pressure Gradient Measured by HVPG and EUS-PPG Techniques
研究概览
简要总结
This study aims to evaluate the accuracy and safety of a novel endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement technique in 42 adults with liver cirrhosis and portal vein thrombosis (blood clots in the liver's main vein), a condition where current standard testing (HVPG) fails to provide reliable pressure readings. Participants will undergo both EUS-PPG (using a specialized needle under ultrasound guidance) and HVPG procedures to compare results; EUS-PPG will be performed under general anesthesia in a left-side lying position-an innovative approach-while also enabling immediate endoscopic treatment of bleeding veins if detected during the same session. The primary goals are to validate EUS-PPG's safety in this high-risk group, establish its correlation with HVPG, and pioneer an integrated diagnosis-treatment protocol to reduce hospital stays and costs. The study runs from July 2025 to June 2027 at Zhejiang University School of Medicine.
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 old
- •History of liver cirrhosis
- •INR < 1.5
- •Platelet count > 50 × 10⁹/L
- •Patients agreed to HVPG and EUS-PPG measurements
排除标准
- •Patients with ascites
- •Patients with renal insufficiency
- •Patients with active infection
- •Patients with hepatic encephalopathy
- •Critically ill patients
- •Pregnant patients
- •Patients with immunodeficiency diseases (such as systemic lupus erythematosus)
- •Patients with mental illness
- •Patients with malignant tumors
- •Patients who refused to undergo HVPG and EUS-PPG measurements
研究组 & 干预措施
hepatic venous pressure gradient, HVPG
After puncturing the internal jugular vein, under the guidance of the image monitor, the balloon catheter is inserted into the hepatic vein along the blood vessel to measure the free hepatic venous pressure (FHVP), and then the balloon is inflated to measure the wedged hepatic venous pressure (WHVP). The difference between the two is the hepatic venous pressure gradient.
干预措施: endoscopic ultrasound-guided portal pressure gradient (Procedure)
结局指标
主要结局
Mean Portal Pressure Gradient Measured by HVPG and EUS-PPG Techniques
时间窗: From enrollment, treatment was completed within 1 week
The internal jugular vein is punctured and the difference between the wedge hepatic venous pressure (WHVP) and the free hepatic venous pressure (FHVP) is measured as the hepatic venous pressure gradient (HVPG). Endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) refers to the measurement of data by passing the puncture needle through the digestive tract into the portal vein system, hepatic vein or inferior vena cava system under the guidance of a linear array ultrasound endoscope.Portal vein pressure (PVP): The normal portal vein pressure is 1.27-2.35 kPa (13-24 cmH2O)
次要结局
- Incidence of surgery-related complications(From enrollment, treatment was completed within 1 week)
- Direct medical cost of treatment(From enrollment, treatment was completed within 1 week)
研究者
Xiaolong Zheng
Principal Investigator
Zhejiang University