EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) and measured via the hepatic venous pressure gradient (HVPG).
研究概览
简要总结
The goal of this investigator-initiated, single-arm, prospective study is to evaluate the accuracy, safety, and feasibility of endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement as a potential alternative to the traditional hepatic venous pressure gradient (HVPG) method in patients with portal hypertension due to chronic liver disease. The main questions it aims to answer are:
- What is the correlation between EUS-PPG and HVPG measurements in patients with portal hypertension due to cirrhosis?
- Can EUS-PPG serve as a reliable and less invasive alternative to HVPG for assessing portal pressure?
- What are the safety outcomes associated with EUS-PPG compared to HVPG?
Researchers will compare EUS-PPG measurements with HVPG measurements within the same patients to assess whether EUS-PPG provides accurate and clinically comparable portal pressure readings while reducing procedural risks.
Participants will:
- Be adults aged 18 to 85 with a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
- Undergo both EUS-PPG and HVPG measurements within a seven-day window to allow for direct comparison of results.
- Receive standard clinical care for their condition, including routine diagnostic evaluations and portal hypertension management as needed.
- Be monitored for safety outcomes, including adverse events such as bleeding, infection, perforation, and any other complications related to the procedure.
- Provide relevant demographic and clinical data, including liver disease history, Child-Pugh and MELD scores, and portal hypertension-related complications such as varices or ascites.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 18 to 85 years of age inclusive, at the time of signing the informed consent form.
- •Subjects who have a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
- •Subjects capable of giving signed informed consent.
排除标准
- •Pregnancy.
- •Significant bleeding risk (International Normalized Ratio (INR) > 1.5 OR platelet count < 50000).
- •Presence of active gastrointestinal bleeding at the time of screening
- •History of any blood thinner consumption (e.g. warfarin, heparin, novel roal anticoagulants) within the last 5 days.
- •Presence of massive ascites causing abdominal distension or requiring frequent therapeutic paracentesis.
- •Subjects having received previous Transjugular Intrahepatic Portosystemic Shunt (TIPS) or Surgical Portosystemic Shunt.
- •Hepatocellular carcinoma not meeting Milan Criteria.
- •Presence of portal vein thrombosis or another suspected component of presinusoidal portal hypertension.
- •Presence of extra-hepatic cancer, terminal disease, or severe comorbidities significantly limiting life expectancy or affecting study participation.
- •Stenosis or surgical anatomical alterations of the gastrointestinal tract that could preclude endoscopic access with the echoendoscope.
研究组 & 干预措施
EUS-PPG and HVPG Measurement in Portal Hypertension
干预措施: Endoscopic Ultrasound-Guided Portal Pressure Gradient (EUS-PPG) Measurement (Diagnostic Test)
EUS-PPG and HVPG Measurement in Portal Hypertension
干预措施: Hepatic Venous Pressure Gradient (HVPG) Measurement (Diagnostic Test)
结局指标
主要结局
Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) and measured via the hepatic venous pressure gradient (HVPG).
时间窗: 7 days
Correlation between the portosystemic pressure gradient (PPG) measured directly via endoscopic ultrasonography (EUS-PPG) using the EchoTip® Insight™ needle and the hepatic venous pressure gradient (HVPG) measured through hepatic vein catheterization in patients with chronic portal hypertension due to liver cirrhosis.
次要结局
未报告次要终点