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Completed
NCT04315571
Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents
Conditions: Hypertension, Portal, Ascites
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 68
Sponsor: University of California, Los Angeles
Location: UCLA Medical Center Los Angeles California
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.
Eligibility Criteria
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 \ 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)).
Source: ClinicalTrials.gov (NCT04315571). StuddyBuddy aggregates publicly available trial information.