EUS-portal Pressure Gradient (EUS-PPG). Prospective Study Compared With Hepatic Venous Pressure Gradient (HVPG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Intra-class correlation coefficient between portal pressure gradient measurement by EUS and hepatic venous pressure gradient measurement measured by interventional radiology.
研究概览
简要总结
The objective of this study is to evaluate the correlation of the calculated portal pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with a conventional 22 G needle guided by EUS and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years
- •Undergoing evaluation for chronic liver disease or portal hypertension
- •Signed informed consent
排除标准
- •Uncorrectable coagulopathy (INR above 1.5)
- •Uncorrectable thrombocytopenia (Platelets under 50,000)
- •Anticoagulation or antiplatelet therapy that cannot be discontinued
- •Biliary obstruction
- •Grade II ascites or more
- •Intrahepatic portal vein thrombosis
- •Pregnancy
结局指标
主要结局
Intra-class correlation coefficient between portal pressure gradient measurement by EUS and hepatic venous pressure gradient measurement measured by interventional radiology.
时间窗: 1 day
Portal pressure gradient measurement will be performed by direct echoendoscopy-guided puncture with a 22 G needle of the portal vein and the suprahepatic vein. On the same day or on successive days, hepatic venous pressure gradient determination will be performed by interventional radiology. For this purpose, the free hepatic venous pressure and the wedged pressure will be measured using a balloon catheter and jugular approach, following the usual procedure.
次要结局
- Technical success of both procedures measured as the number of procedures successfully performed divided by the total number of patients.(1 day)
- Adverse effects at 30 days after each procedure by clinical follow-up of patients at 24 hours, 7 days, and 30 days using the American Society of Gastrointestinal Endoscopy Severity grading system, from mild to fatal.(30 days)
研究者
Jose Ramon Aparicio Tormo
Head of Endoscopy Unit
Hospital General Universitario de Alicante