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临床试验/NCT07478770
NCT07478770已完成不适用

Study on Portal Vein Pressure Gradient Measurement Under Endoscopic Ultrasound Guidance for Gastric Fundal Varices

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
HVPG

研究概览

简要总结

This study aimed to evaluate the feasibility and safety of direct gastric variceal pressure measurement in patients with large spontaneous portosystemic shunts, and to determine whether the gastric variceal pressure gradient (GVPG)-defined as directly measured gastric variceal pressure (GVP) minus hepatic vein pressure (HVP)-offers superior predictive value for bleeding risk compared to conventional HVPG and EUS-PPG in this challenging patient population.

研究设计

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

入排标准

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

入选标准

  • (1) age≥18 years; (2) hospitalized patients with a confirmed diagnosis of cirrhosis with gastric varices and large spontaneous shunts based on clinical, laboratory, and imaging findings; and (3) provided written informed consent for all diagnostic and therapeutic procedures.

排除标准

  • (1) significant coagulopathy, defined as an international normalized ratio (INR) > 1.5; (2) severe thrombocytopenia (platelet counts < 20×10^9/L); (3) presence of severe systemic comorbidities, such as active sepsis, decompensated heart failure, or severe chronic obstructive pulmonary disease; (4) psychiatric disorders precluding procedure cooperation; (5) concurrent malignant tumors; or (6) 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

HVPG

时间窗: From enrollment to the end of treatment at 4 weeks

EUS-PPG

时间窗: From enrollment to the end of treatment at 4 weeks

GVPG

时间窗: From enrollment to the end of treatment at 4 weeks

次要结局

未报告次要终点

研究者

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

研究点 (1)

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