Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
Edward W Lee, M.D. (ucla)

Description

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.

Official Title

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

Details

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.

Keywords

Hypertension, Portal Ascites end-stage liver disease hepatic encephalopathy cirrhosis Gore® Viatorr® Endoprosthesis with controlled expansion Large Volume Paracentesis with albumin infusion

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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)).

Location

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Health

  • Edward W Lee, M.D. (ucla)
    Associate Professor of Clinical , Radiological Sciences. Authored (or co-authored) 5 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04315571
Study Type
Interventional
Last Updated