Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Portal Pressure Gradient Measurements from Hepatic and Portal Veins
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies.
详细描述
Patients undergoing EUS-guided liver biopsy may qualify to participate in this study. The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS- Portal Pressure Gradient Measurement (PPGM) in patients with liver disease referred for EUS-guided liver biopsy.
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
- •Age 18 years or older
- •Patient who has been referred for EUS procedure and direct PPG measurement and -undergoing EUS-guided liver biopsy
- •History of liver disease or suspected cirrhosis and considered for PPGM
排除标准
- •Patient is less than 18 or greater than 85 years of age
- •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 for whom endoscopic procedures are contraindicated.
研究组 & 干预措施
Treatment
Patients undergoing Endoscopic-Ultrasound Guided liver biopsies and Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurements
干预措施: Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement (Procedure)
结局指标
主要结局
Portal Pressure Gradient Measurements from Hepatic and Portal Veins
时间窗: 2 years
A catheter is inserted into the hepatic vein before hepatic venous pressure and portal vein pressure are recorded
次要结局
- Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension(2 years)
- Clinical significance between portal pressure gradient measurement and portal hypertension(2 years)