Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements vs. Transjugular Balloon Occlusion Measurement: A Multicenter EU Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- The correlation between the direct and indirect procedures to measure PPG.
研究概览
简要总结
The objective of this study is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® Insight™ 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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with cirrhosis who have been referred for a procedure where HVPG is obtained.
排除标准
- •Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
- •Patient is unwilling or unable to sign and date the informed consent
- •Patient is unwilling to comply with the follow-up study schedule
- •Previous total or partial splenectomy
- •Non-cirrhotic portal hypertension
- •Known history of spontaneous bacterial peritonitis (SBP) within the last three months irrespective of treatment for SBP
- •Patients with known infection which is not controlled by medical intervention
- •Portopulmonary hypertension
- •Cardiac decompensation
- •Pre-sinusoidal liver disease
- •Cholestatic liver disease
- •Patient who received endoscopic treatment for upper gastrointestinal (GI) variceal bleeding within the past 7 days
- •Patients with current hepatocellular carcinoma (HCC)
结局指标
主要结局
The correlation between the direct and indirect procedures to measure PPG.
时间窗: The period from the start of the procedure until all measurements are completed is anticipated to be approximately two hours
Under general anesthesia, to quantify the correlation between the calculated PPG from the EchoTip® Insight™ direct measurements (difference between direct portal vein pressure and direct hepatic vein pressure) and indirect HVPG measurement (difference between transjugular free hepatic venous pressure (FHVP) and wedge hepatic venous pressure (WHVP) obtained during an IR procedure.
次要结局
未报告次要终点