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Endoprosthesis

Paracentesis vs. TIPS for Ascites

N/A
Waitlist Available
Led By Edward W Lee, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No malignancy (must be a definite diagnosis)
Patent internal or external jugular vein
Must not have
Age <18
Liver failure (Child Pugh > 12)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two approved treatments for ascites: large volume paracentesis with albumin infusion (Group A) or early transjugular intrahepatic portosystemic shunt (Group B).

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include discomfort at puncture sites, infection risk from procedures, potential liver issues after TIPS, and fluid-electrolyte imbalances post-paracentesis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not been diagnosed with any form of cancer.
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My jugular vein is not blocked.
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I am getting my first TIPS procedure for portal hypertension.
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I have had fluid drained from my abdomen at least twice in the last 3 weeks.
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I do not have a known blood clotting disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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My liver is functioning well (Child Pugh ≤ 12).
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I have heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Paracentesis
Secondary study objectives
Transplant free survival
Other study objectives
Stent diameter change

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Group AActive Control1 Intervention
Routine Large Volume Paracentesis (LVP) with albumin infusion
Group II: Group BActive Control1 Intervention
Early Transjugular intrahepatic portosystemic shunt (TIPS) procedure using Gore Viatorr CX

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,121 Total Patients Enrolled
1 Trials studying Ascites
1,000 Patients Enrolled for Ascites
W.L.Gore & AssociatesIndustry Sponsor
100 Previous Clinical Trials
32,721 Total Patients Enrolled
1 Trials studying Ascites
26 Patients Enrolled for Ascites
Edward W Lee, MD, PhDPrincipal InvestigatorUniversity of California

Media Library

Gore® Viatorr® Endoprosthesis (Endoprosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT04315571 — N/A
Ascites Research Study Groups: Group A, Group B
Ascites Clinical Trial 2023: Gore® Viatorr® Endoprosthesis Highlights & Side Effects. Trial Name: NCT04315571 — N/A
Gore® Viatorr® Endoprosthesis (Endoprosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04315571 — N/A
~13 spots leftby Jan 2026
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