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

NCT04315571 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-05-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Edward W Lee, MD, PhD · University of California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-24
Primary Completion
2026-04-01
Completion
2027-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04315571 on ClinicalTrials.gov