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

68 Participants Needed

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.

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.

What data supports the effectiveness of the treatment Gore® Viatorr® Endoprosthesis, Large Volume Paracentesis with albumin infusion for ascites?

A study comparing TIPS (a type of shunt) and large-volume paracentesis with albumin in patients with severe ascites found that TIPS improved survival rates without the need for liver transplantation compared to paracentesis with albumin. However, paracentesis with albumin is still widely used and can be performed safely, even in outpatient settings, by trained personnel. ^{1 2 3 4 5}

Is the TIPS procedure with the Viatorr stent generally safe for humans?

The TIPS procedure using the Viatorr stent is generally considered safe, with a high success rate and a good survival rate at 12 and 24 months. However, there is a risk of hepatic encephalopathy (a brain condition caused by liver disease) after the procedure, which occurs in some patients. ^{2 6 7 8 9}

How does the treatment of Paracentesis vs. TIPS for Ascites differ from other treatments?

The treatment using the Gore® Viatorr® Endoprosthesis for TIPS (a procedure to create a new pathway for blood flow in the liver) is unique because it effectively reduces portal pressure and rebleeding rates, while maintaining a high survival rate and not significantly increasing the risk of hepatic encephalopathy (a brain disorder caused by liver dysfunction). In contrast, large-volume paracentesis with albumin infusion is a simpler procedure that helps relieve fluid buildup in the abdomen but may require repeated sessions and careful management to avoid complications. ^{1 2 6 9 10}

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.

Timeline

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

Treatment Details

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.

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+

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

References

1. Iran pubmed.ncbi.nlm.nih.gov

Evaluation of Outcomes and Complications of Large Volume Paracentesis without Albumin and Coagulopathy Therapy in Pediatrics with Severe Ascites. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

Therapy of the refractory ascites: Total paracentesis vs. TIPS. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled study of TIPS versus paracentesis plus albumin in cirrhosis with severe ascites. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Performance standards for therapeutic abdominal paracentesis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Expanded PTFE-covered stent-grafts in the treatment of transjugular intrahepatic portosystemic shunt (TIPS) stenoses and occlusions. [2005]

7. United States pubmed.ncbi.nlm.nih.gov

VIDEO: Technique to Restrict the Gore Viatorr Stent-Graft for TIPS Reduction. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

TIPS with expanded polytetrafluoroethylene-covered stent: results of an Italian multicenter study. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Clinical study of transjugular intrahepatic portosystemic shunt with Viatorr stent in 43 cases]. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Renaissance of paracentesis in the treatment of ascites. [2007]