Paracentesis vs. TIPS for Ascites

Overseen By Saima C Chaabane, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Liver failure, Cardiac failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two treatments for ascites, a condition where excess fluid builds up in the abdomen due to liver issues. Participants will be randomly assigned to receive either routine Large Volume Paracentesis (LVP), which involves draining the fluid with an albumin infusion, or an early TIPS procedure (a shunt placed in the liver to improve blood flow) using the Gore® Viatorr® Endoprosthesis. The trial seeks individuals with recurring ascites that require frequent fluid drainage. Participants should not have conditions such as liver failure or heart issues. This study will help determine which treatment is more effective for managing ascites. As an unphased trial, it offers participants the chance to contribute to valuable research that could improve future treatment options for ascites.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both treatments under study are generally safe and well-tolerated.

The Gore Viatorr Endoprosthesis, used in the TIPS procedure, has proven safe and effective for treating conditions like high blood pressure in the liver and fluid buildup in the abdomen (ascites). One study reported a 100% success rate in the technical aspects of the procedure, with most patients experiencing improvement in their ascites condition.

Large Volume Paracentesis (LVP) with albumin infusion is also considered safe. Studies highlight its effectiveness when albumin is used, as it helps prevent complications like circulation issues. Managing the amount of fluid removed is crucial to ensure safety.

Both treatments have been widely used and researched, providing reassurance about their safety in managing ascites. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the use of Transjugular Intrahepatic Portosystemic Shunt (TIPS) with the Gore Viatorr CX because it offers a unique approach to managing ascites by directly addressing portal hypertension, a key underlying issue. Unlike standard treatments like repeated Large Volume Paracentesis (LVP) with albumin infusion, which only temporarily relieve fluid buildup, TIPS can potentially provide a more lasting solution by rerouting blood flow in the liver to reduce pressure. This procedure could reduce the need for frequent hospital visits for fluid removal, improving quality of life for patients with ascites.

What evidence suggests that this trial's treatments could be effective for ascites?

This trial will compare two treatments for ascites: Large Volume Paracentesis (LVP) with albumin infusion and the Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure using the Gore Viatorr Endoprosthesis. Studies have shown that TIPS effectively treats ascites by lowering pressure in the liver's blood vessels, often leading to long-term improvements. In contrast, LVP with albumin infusion quickly relieves symptoms by removing excess fluid, significantly improving quality of life by reducing pain and discomfort. Both treatments effectively manage ascites, each offering distinct benefits. ^{1 2 3 6 7}

Who Is on the Research Team?

Edward W Lee, MD, PhD

Principal Investigator

University of California

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Large Volume Paracentesis (LVP) with albumin infusion or an early TIPS procedure using Gore Viatorr CX

Immediate procedure

Follow-up

Participants are monitored for clinical outcomes, complications, and rate of secondary interventions

12 months

Follow-up visits at 1 month, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Gore® Viatorr® Endoprosthesis
• Large Volume Paracentesis with albumin infusion

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.

How Is the Trial Designed?

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+

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

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf4/P040027b.pdf

Summary of Safety and Effectiveness Data - accessdata.fda.gov The objectives of the clinical studies were to assess the safety and effectiveness of the. GORE VIA TORR TIPS Endoprosthesis in the de novo and/or revision ...

2. goremedical.com goremedical.com/products/viatorr

VIATORR® TIPS Endoprosthesis GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion treats portal hypertension and complications like variceal bleeding and refractory ascites.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9248993/

Elective Transjugular Intrahepatic Portosystemic Shunt Using ... Elective TIPS implantation using Viatorr TIPS stent-grafts is generally safe, and the long-term efficacy is favorable for the treatment of cirrhotic patients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8822954/

Outcomes After TIPS for Ascites and Variceal Bleeding in a ... Among 1,129 TIPS recipients, 58% received TIPS for ascites/HH and 42% for variceal bleeding. In patients who underwent TIPS for ascites/HH, the subdistribution ...

5. ajronline.org ajronline.org/doi/10.2214/ajr.185.2.01850472

TIPS with Expanded Polytetrafluoroethylene–Covered Stent RESULTS. The procedure was successful in 113 (99.1%) of 114 patients; in one patient, creation of the track was not feasible. The mean portosystemic pressure ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01236339

Study Details | NCT01236339 | Early TIPS for Ascites Study The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in ...

7. ajronline.org ajronline.org/doi/10.2214/AJR.14.12885

TIPS for Refractory Ascites: A 6-Year Single-Center ... Immediate technical success of the TIPS procedure was 100%. Of the 61 patients with documented follow-up, 55 (90.2%) had a partial or complete ascites response ...