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

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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)).

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Study Stats
Protocol No.
20-000160
Category
Radiological Sciences
Principal Investigator
Edward Wolfgang Lee
Contact
Arineh Aghakhani
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04315571
For detailed technical eligibility, visit ClinicalTrials.gov.