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

Effective Ascites ReLief In earlY TIPS (EARLY TIPS) Using Viatorr CX vs. LVP Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ascites; Hypertension, Portal
• Intervention / Treatment: Procedure: Large Volume Paracentesis with albumin infusion; Device: Gore® Viatorr® Endoprosthesis with controlled expansion

Detailed Description

End Stage Liver Disease (ESLD) severely impacts body function leading to elevated blood pressure within the liver called "portal hypertension." One of its subsequent symptoms is ascites, or fluid accumulation in the abdomen. One standard treatment to relieve ascites is large volume paracentesis (puncture of the abdomen to drain the fluid). Another standard treatment is the TIPS procedure, which involves creating a shunt (small passage allowing fluid movement) within the liver to relieve the increased blood pressure in the liver.

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.

The study will include about 68 patients (34 patients will be selected for Group A: continuing conservative treatment of LVP with albumin infusion, and 34 patients will be selected for Group B: undergoing early TIPS with Gore®Viatorr®CX). Each patient will be followed up at 1 month, 3 months, 6 months, and 12 months.

The primary objective of this study is to evaluate the overall clinical efficacy in symptom relief of ascites of patients receiving the Gore® Viatorr® CX in early TIPS procedures compared to LVP (large volume paracenthesis). In order to so, the investigators will be using information found in patient medical records, collected as a part of standard of care, to analyze clinical outcomes, complications, and the rate of secondary interventions at follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males and females > 18 years of age at time of procedure
• First de novo TIPS placement
• Patent internal or external jugular vein
• Willing to provide the hepatology service information for follow up
• No known diagnosis of hypercoagulopathy
• No portal vein thrombosis
• No malignancy (must be a definite diagnosis)
• Patient must provide written informed consent

• Proper clinical indication of TIPS based on American Association for the Study of Liver Diseases (AASLD) guidelines

  • Recurrent ascites necessitating at least 2 large volume paracenteses performed within a minimum interval of 3 weeks

Exclusion Criteria:

• Age <18
• LVP > 6 times in 2 months
• Liver failure (Child Pugh > 12)
• Cardiac failure
• No right jugular venous access
• Absolute TIPS contraindications (e.g. right heart failure, severe encephalopathy, liver failure, pregnant (if possible)).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Routine Large Volume Paracentesis (LVP) with albumin infusion	Procedure: Large Volume Paracentesis with albumin infusion; For therapeutic (large-volume) paracentesis, a 14-gauge cannula attached to a vacuum aspiration system is used to collect up to 8 L of ascitic fluid. Concurrent infusion of IV albumin is recommended during large-volume paracentesis to help avoid significant intravascular volume shift and postprocedural hypotension.; Other Names: LVP with albumin infusion
Active Comparator: Group B; Early Transjugular intrahepatic portosystemic shunt (TIPS) procedure using Gore Viatorr CX	Device: Gore® Viatorr® Endoprosthesis with controlled expansion; TIPS (Transjugular Intrahepatic Portosystemic Shunt) is a minimally invasive procedure in which a new path is made through the liver to carry blood from the portal vein to the heart, thus helping to alleviate the problems associated with elevated portal vein pressure.; Other Names: TIPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Paracentesis	The average number of paracentesis per week.	1 year post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transplant free survival	Overall survival without transplant after the treatment	1 year post-procedure or until the patient expires or receives transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent diameter change	Stent diameter changes from the time of TIPS placement	1 month and 6 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: W.L.Gore & Associates
• Investigators: Principal Investigator: Edward W Lee, MD, PhD, University of California

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2020
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: end-stage liver disease; hepatic encephalopathy; cirrhosis
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Hypertension, Portal; Ascites
• Other Study ID Numbers: CXTIPSvLVP-v1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes