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

NCT04315571 | Active Not Recruiting FDA Device

• 1 other identifier: CXTIPSvLVP-v1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Portal; Ascites

Keywords

end-stage liver disease; hepatic encephalopathy; cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of Paracentesis

  The average number of paracentesis per week.

  1 year post-procedure

Secondary Outcomes (1)

• Transplant free survival

  1 year post-procedure or until the patient expires or receives transplant

Other Outcomes (1)

• Stent diameter change

  1 month and 6 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Routine Large Volume Paracentesis (LVP) with albumin infusion

Procedure: Large Volume Paracentesis with albumin infusion

Group B

ACTIVE COMPARATOR

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

Device: Gore® Viatorr® Endoprosthesis with controlled expansion

Interventions

Gore® Viatorr® Endoprosthesis with controlled expansion 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.

Also known as: TIPS

Group B

Large Volume Paracentesis with albumin infusion 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.

Also known as: LVP with albumin infusion

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• W.L.Gore & Associates: collaborator

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 38235907 DERIVED

MeSH Terms

Conditions

Hypertension, Portal; Ascites; End Stage Liver Disease; Hepatic Encephalopathy; Fibrosis

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Edward W Lee, MD, PhD

  University of California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology and Surgery

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 19, 2020
• Study Start: March 24, 2020
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)