Clinical trial NCT04315571: Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents
Official title: Effective Ascites ReLief In earlY TIPS (EARLY TIPS) Using Viatorr CX vs. LVP Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension, Portal
Ascites
Keywords: end-stage liver disease
hepatic encephalopathy
cirrhosis
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: W.L.Gore & Associates
First posted: 2020-03-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

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 \<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)).

Primary outcomes:
measure: Number of Paracentesis
timeFrame: 1 year post-procedure
Secondary outcomes:
measure: Transplant free survival
timeFrame: 1 year post-procedure or until the patient expires or receives transplant
Other outcomes:
measure: Stent diameter change
timeFrame: 1 month and 6 months
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
Study officials:
affiliation: University of California
name: Edward W Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: