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临床试验/NCT07782554
NCT07782554已完成不适用

Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement in Patients With Prehepatic Portal Hypertension: A Retrospective Observational Study

Second Affiliated Hospital, Zhejiang University, School of Medicine1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
试验地点
1
主要终点
Correlation Between EUS-Guided Portal Pressure Gradient and Hepatic Venous Pressure Gradient

研究概览

简要总结

Portal hypertension caused by prehepatic vascular obstruction, such as portal vein thrombosis or portal vein tumor thrombosis, represents a unique hemodynamic condition in which conventional hepatic venous pressure gradient (HVPG) measurement may not accurately reflect portal venous pressure. Endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement provides a direct approach for assessing portal hemodynamics.

This retrospective observational study included patients with cirrhosis and esophagogastric varices complicated by portal vein thrombosis or portal vein tumor thrombosis. All patients underwent abdominal computed tomography to confirm the presence of portal vein obstruction, liver stiffness measurement by ultrasound elastography, HVPG measurement, and EUS-PPG measurement. The study aims to evaluate the relationship between EUS-PPG and HVPG and to explore the associations between portal pressure measurements and clinical characteristics, including underlying liver disease etiology, liver function grade, sex, gastrointestinal bleeding, and hepatic encephalopathy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years; Confirmed diagnosis of cirrhosis complicated by portal venous obstructionbased on clinical, laboratory, and imaging findings; Written informed consent;

排除标准

  • Severe coagulopathy, defined as an International Normalized Ratio (INR) >1.5; Severe thrombocytopenia, defined as a platelet count <30 × 10^9/L; Severe systemic comorbidities, including active sepsis, decompensated heart failure, or severe chronic obstructive pulmonary disease; Psychiatric or cognitive disorders that preclude cooperation with study procedures; Refusal to undergo hepatic venous pressure gradient (HVPG) or endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement;

结局指标

主要结局

Correlation Between EUS-Guided Portal Pressure Gradient and Hepatic Venous Pressure Gradient

时间窗: Periprocedural

The correlation between portal pressure gradient measured by endoscopic ultrasound-guided direct portal pressure measurement (EUS-PPG) and hepatic venous pressure gradient (HVPG) will be assessed using paired measurements obtained during the same procedural session. Both EUS-PPG and HVPG are measured in mmHg. The strength of the correlation will be quantified using a correlation coefficient.

次要结局

  • Difference Between Distal-to-Obstruction and Proximal-to-Obstruction EUS-Guided Portal Pressure Gradients(Periprocedural)
  • Difference Between Distal-to-Obstruction EUS-Guided Portal Pressure Gradient and Hepatic Venous Pressure Gradient(Periprocedural)
  • Difference in Distal-to-Obstruction EUS-Guided Portal Pressure Gradient Between Patients With and Without Variceal Bleeding(Baseline)

研究者

发起方
Second Affiliated Hospital, Zhejiang University, School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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