Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents

  • STATUS
    Recruiting
  • End date
    Jan 1, 2026
  • participants needed
    68
  • sponsor
    University of California, Los Angeles
Updated on 2 March 2022
cancer
ascites
paracentesis
portosystemic shunt

Summary

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.

Description

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 GoreViatorrCX). 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.

Details
Condition Hypertension, Portal, Ascites
Treatment Gore® Viatorr® Endoprosthesis with controlled expansion, Large Volume Paracentesis with albumin infusion
Clinical Study IdentifierNCT04315571
SponsorUniversity of California, Los Angeles
Last Modified on2 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Age <18
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))
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