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

NCT ID: NCT04315571

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-24
• Study Completion Date: 2027-04-01

Brief Summary

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.

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.

Conditions

Hypertension, Portal; Ascites

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Routine Large Volume Paracentesis (LVP) with albumin infusion

Group Type: ACTIVE_COMPARATOR

Large Volume Paracentesis with albumin infusion

Intervention Type: PROCEDURE

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.

Group B

Early Transjugular intrahepatic portosystemic shunt (TIPS) procedure using Gore Viatorr CX

Group Type: ACTIVE_COMPARATOR

Gore® Viatorr® Endoprosthesis with controlled expansion

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

TIPS; LVP with albumin infusion

Eligibility Criteria

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)).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Edward Wolfgang Lee, MD

Associate Professor of Radiology and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward W Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California

Locations

UCLA Medical Center

Los Angeles, California, United States

Countries

United States

References

Gonzalez-Garay AG, Serralde-Zuniga AE, Velasco Hidalgo L, Flores Garcia NC, Aguirre-Salgado MI. Transjugular intrahepatic portosystemic shunts for adults with hepatorenal syndrome. Cochrane Database Syst Rev. 2024 Jan 18;1(1):CD011039. doi: 10.1002/14651858.CD011039.pub2.

Reference Type: DERIVED

PMID: 38235907 (View on PubMed)

Other Identifiers

CXTIPSvLVP-v1

Identifier Type: -

Identifier Source: org_study_id