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

Ascites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04315571
• Other study ID #: CXTIPSvLVP-v1
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 24, 2020
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)).

Related Conditions & MeSH terms

• Ascites
• Hypertension, Portal

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stent diameter change	Stent diameter changes from the time of TIPS placement	1 month and 6 months
Primary	Number of Paracentesis	The average number of paracentesis per week.	1 year post-procedure
Secondary	Transplant free survival	Overall survival without transplant after the treatment	1 year post-procedure or until the patient expires or receives transplant