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Endoprosthesis

Paracentesis vs. TIPS for Ascites

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-procedure

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-procedure

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Paracentesis

Secondary outcome measures

Transplant free survival

Other outcome measures

Stent diameter change

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,278,134 Total Patients Enrolled

1 Trials studying Ascites

1,000 Patients Enrolled for Ascites

W.L.Gore & AssociatesIndustry Sponsor

95 Previous Clinical Trials

28,259 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment rate of this research endeavor?

"Yes, information on clinicaltrials.gov validates that this investigation is currently enrolling subjects. This experiment was originally listed on March 24th 2020 and last updated on September 1st 2022; it plans to accept 68 individuals from a single site."

Answered by AI

Are there any spots left open for participants in this experiment?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical research is actively seeking volunteers and was initially posted in March of 2020 before being updated last September. 68 recruits are needed from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Edward Wolfgang Lee, MD 2020. "Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04315571.

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