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

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT04315571
Collaborator
W.L.Gore & Associates (Industry)
68
Enrollment
1
Location
2
Arms
69.3
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Gore® Viatorr® Endoprosthesis with controlled expansion
  • Procedure: Large Volume Paracentesis with albumin infusion
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effective Ascites ReLief In earlY TIPS (EARLY TIPS) Using Viatorr CX vs. LVP Study
Actual Study Start Date :
Mar 24, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

Routine Large Volume Paracentesis (LVP) with albumin infusion

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.
Other Names:
  • LVP with albumin infusion

    		•
    Active Comparator: Group B

    Early Transjugular intrahepatic portosystemic shunt (TIPS) procedure using Gore Viatorr CX

    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.
    Other Names:
  • TIPS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Paracentesis [1 year post-procedure]

      The average number of paracentesis per week.

    Secondary Outcome Measures

    1. Transplant free survival [1 year post-procedure or until the patient expires or receives transplant]

      Overall survival without transplant after the treatment

    Other Outcome Measures

    1. Stent diameter change [1 month and 6 months]

      Stent diameter changes from the time of TIPS placement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Medical Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • University of California, Los Angeles
    • W.L.Gore & Associates

    Investigators

    • Principal Investigator: Edward W Lee, MD, PhD, University of California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edward Wolfgang Lee, MD, Associate Professor of Radiology and Surgery, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT04315571
    Other Study ID Numbers:
    • CXTIPSvLVP-v1
    First Posted:
    Mar 19, 2020
    Last Update Posted:
    Aug 13, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Edward Wolfgang Lee, MD, Associate Professor of Radiology and Surgery, University of California, Los Angeles
    end-stage liver disease
    hepatic encephalopathy
    cirrhosis
    Additional relevant MeSH terms:
    Hypertension, Portal
    Ascites

    Study Results

    No Results Posted as of Aug 13, 2021