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Completed

NCT Number: NCT04315571

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)).

Treatment and study plan

Gore® Viatorr® Endoprosthesis with controlled expansion

Device

TIPS (Transjugular Intrahepatic Portosystemic Shunt) is a minimally invasive procedure in which a new path is made through the liver to carry blood from the portal vein to the heart, thus helping to alleviate the problems associated with elevated portal vein pressure.

Other names: TIPS

Large Volume Paracentesis with albumin infusion

Procedure

For therapeutic (large-volume) paracentesis, a 14-gauge cannula attached to a vacuum aspiration system is used to collect up to 8 L of ascitic fluid. Concurrent infusion of IV albumin is recommended during large-volume paracentesis to help avoid significant intravascular volume shift and postprocedural hypotension.

Other names: LVP with albumin infusion

Primary outcomes

  1. Number of Paracentesis

    Time frame: 1 year post-procedure

    The average number of paracentesis per week.

Secondary outcomes

  1. Transplant free survival

    Time frame: 1 year post-procedure or until the patient expires or receives transplant

    Overall survival without transplant after the treatment

Other outcomes

  1. Stent diameter change

    Time frame: 1 month and 6 months

    Stent diameter changes from the time of TIPS placement

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • W.L.Gore & Associates

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2020
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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