Status:
ACTIVE_NOT_RECRUITING
Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
W.L.Gore & Associates
Conditions:
Hypertension, Portal
Ascites
Eligibility:
All Genders
18+ years
Phase:
NA
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 eithe...
Detailed Description
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 accu...
Eligibility Criteria
Inclusion
- 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
- 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)).
Key Trial Info
Start Date :
March 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04315571
Start Date
March 24 2020
End Date
April 1 2027
Last Update
May 1 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA Medical Center
Los Angeles, California, United States, 90095