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临床试验/NCT04315571
NCT04315571已完成不适用

Effective Ascites ReLief In earlY TIPS (EARLY TIPS) Using Viatorr CX vs. LVP Study

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年3月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Number of Paracentesis

研究概览

简要总结

For this study, the investigators will be collecting data based on patients' random selection to two different approved standard of care treatments for ascites: Subjects will get randomized into either Group A: Large Volume Paracentesis (LVP) with albumin infusion, or Group B: an early transjugular intrahepatic portosystemic shunt (TIPS) procedure.

详细描述

End Stage Liver Disease (ESLD) severely impacts body function leading to elevated blood pressure within the liver called "portal hypertension." One of its subsequent symptoms is ascites, or fluid accumulation in the abdomen. One standard treatment to relieve ascites is large volume paracentesis (puncture of the abdomen to drain the fluid). Another standard treatment is the TIPS procedure, which involves creating a shunt (small passage allowing fluid movement) within the liver to relieve the increased blood pressure in the liver.

For this study, the investigators will be collecting data based on patients' random selection to two different approved standard of care treatments for ascites: Subjects will get randomized into either Group A: Large Volume Paracentesis (LVP) with albumin infusion, or Group B: an early transjugular intrahepatic portosystemic shunt (TIPS) procedure.

The study will include about 68 patients (34 patients will be selected for Group A: continuing conservative treatment of LVP with albumin infusion, and 34 patients will be selected for Group B: undergoing early TIPS with Gore®Viatorr®CX). Each patient will be followed up at 1 month, 3 months, 6 months, and 12 months.

The primary objective of this study is to evaluate the overall clinical efficacy in symptom relief of ascites of patients receiving the Gore® Viatorr® CX in early TIPS procedures compared to LVP (large volume paracenthesis). In order to so, the investigators will be using information found in patient medical records, collected as a part of standard of care, to analyze clinical outcomes, complications, and the rate of secondary interventions at follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Males and females > 18 years of age at time of procedure
  • •First de novo TIPS placement
  • •Patent internal or external jugular vein
  • •Willing to provide the hepatology service information for follow up
  • •No known diagnosis of hypercoagulopathy
  • •No portal vein thrombosis
  • •No malignancy (must be a definite diagnosis)
  • •Patient must provide written informed consent
  • •Proper clinical indication of TIPS based on American Association for the Study of Liver Diseases (AASLD) guidelines
  • •Recurrent ascites necessitating at least 2 large volume paracenteses performed within a minimum interval of 3 weeks

排除标准

  • •LVP > 6 times in 2 months
  • •Liver failure (Child Pugh > 12)
  • •Cardiac failure
  • •No right jugular venous access
  • •Absolute TIPS contraindications (e.g. right heart failure, severe encephalopathy, liver failure, pregnant (if possible)).

研究组 & 干预措施

Group A

Active Comparator

Routine Large Volume Paracentesis (LVP) with albumin infusion

干预措施: Large Volume Paracentesis with albumin infusion (Procedure)

Group B

Active Comparator

Early Transjugular intrahepatic portosystemic shunt (TIPS) procedure using Gore Viatorr CX

干预措施: Gore® Viatorr® Endoprosthesis with controlled expansion (Device)

结局指标

主要结局

Number of Paracentesis

时间窗: 1 year post-procedure

The average number of paracentesis per week.

次要结局

  • Transplant free survival(1 year post-procedure or until the patient expires or receives transplant)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edward Wolfgang Lee, MD

Associate Professor of Radiology and Surgery

University of California, Los Angeles

研究点 (1)

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