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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension, Portal, Ascites

Intervention / Treatment
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* Device: Gore® Viatorr® Endoprosthesis with controlled expansion
* Procedure: Large Volume Paracentesis with albumin infusion


Participation Criteria
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Eligibility Criteria
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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)).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Routine Large Volume Paracentesis (LVP) with albumin infusion | Procedure: Large Volume Paracentesis with albumin infusion<br>* 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.<br>* Other names: LVP with albumin infusion;|
| Active Comparator: Group B<br>Early Transjugular intrahepatic portosystemic shunt (TIPS) procedure using Gore Viatorr CX | Device: Gore® Viatorr® Endoprosthesis with controlled expansion<br>* 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.<br>* Other names: TIPS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Paracentesis | The average number of paracentesis per week. | 1 year post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant free survival | Overall survival without transplant after the treatment | 1 year post-procedure or until the patient expires or receives transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end-stage liver disease, hepatic encephalopathy, cirrhosis