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

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ClinicalTrials.gov Identifier: NCT04315571
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : August 13, 2021
Sponsor:
Collaborator:
W.L.Gore & Associates
Information provided by (Responsible Party):
Edward Wolfgang Lee, MD, University of California, Los Angeles

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
Hypertension, Portal Ascites Device: Gore® Viatorr® Endoprosthesis with controlled expansion Procedure: Large Volume Paracentesis with albumin infusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 24, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine


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 Name: 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 Name: TIPS




Primary Outcome Measures :
  1. Number of Paracentesis [ Time Frame: 1 year post-procedure ]
    The average number of paracentesis per week.


Secondary Outcome Measures :
  1. Transplant free survival [ Time Frame: 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 [ Time Frame: 1 month and 6 months ]
    Stent diameter changes from the time of TIPS placement



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04315571


Contacts
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Contact: Arineh Aghakhani 3102671268 aaghakhani@mednet.ucla.edu
Contact: Saima Chaabane 3107948995 schaabane@mednet.ucla.edu

Locations
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United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Edward W Lee, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
W.L.Gore & Associates
Investigators
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Principal Investigator: Edward W Lee, MD, PhD University of California
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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: March 19, 2020    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of California, Los Angeles:
end-stage liver disease
hepatic encephalopathy
cirrhosis
Additional relevant MeSH terms:
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Hypertension, Portal
Ascites
Pathologic Processes
Liver Diseases
Digestive System Diseases