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

NAActive, not recruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

March 24, 2020

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2027

Conditions
Hypertension, PortalAscites
Interventions
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.

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.

Trial Locations (1)

90095

UCLA Medical Center, Los Angeles

All Listed Sponsors
collaborator

W.L.Gore & Associates

INDUSTRY

lead

University of California, Los Angeles

OTHER