Paracentesis vs. TIPS for Ascites

Recruiting in Palo Alto (17 mi)

Overseen by Edward W Lee, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Edward W Lee, MD, PhD

Principal Investigator

University of California

Eligibility Criteria

This trial is for adults over 18 with portal hypertension and ascites, who haven't had more than two large volume paracenteses in three weeks, no liver failure or severe other conditions. They must consent to follow-up and have no blood clotting disorders or malignancies.

Inclusion Criteria

I have not been diagnosed with any form of cancer.

My jugular vein is not blocked.

Patient must provide written informed consent

Exclusion Criteria

Absolute TIPS contraindications (e.g. right heart failure, severe encephalopathy, liver failure, pregnant (if possible))

LVP > 6 times in 2 months

I am under 18 years old.

Treatment Details

Interventions

• Gore® Viatorr® Endoprosthesis (Endoprosthesis)
• Large Volume Paracentesis with albumin infusion (Procedure)

Trial Overview The study compares two standard treatments for ascites due to portal hypertension: one group undergoes Large Volume Paracentesis with albumin infusion, while the other receives an early TIPS procedure using Gore® Viatorr® controlled expansion stents.

Participant Groups

Group I: Group A Active Control 1 Intervention

Routine Large Volume Paracentesis (LVP) with albumin infusion

Group II: Group B Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

W.L.Gore & Associates

Industry Sponsor

Trials

103

Recruited

32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School