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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

Tracking Information
First Submitted Date  ICMJE March 9, 2020
First Posted Date  ICMJE March 19, 2020
Last Update Posted Date August 13, 2021
Actual Study Start Date  ICMJE March 24, 2020
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
Number of Paracentesis [ Time Frame: 1 year post-procedure ]
The average number of paracentesis per week.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
Transplant free survival [ Time Frame: 1 year post-procedure or until the patient expires or receives transplant ]
Overall survival without transplant after the treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
Transplant free survival [ Time Frame: 1 year post-procedure or until the patient expires or recieves transplant ]
Overall survival without transplant after the treatment
Current Other Pre-specified Outcome Measures
 (submitted: March 17, 2020)
Stent diameter change [ Time Frame: 1 month and 6 months ]
Stent diameter changes from the time of TIPS placement
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents
Official Title  ICMJE Effective Ascites ReLief In earlY TIPS (EARLY TIPS) Using Viatorr CX vs. LVP Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension, Portal
  • Ascites
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Group A
    Routine Large Volume Paracentesis (LVP) with albumin infusion
    Intervention: Procedure: Large Volume Paracentesis with albumin infusion
  • Active Comparator: Group B
    Early Transjugular intrahepatic portosystemic shunt (TIPS) procedure using Gore Viatorr CX
    Intervention: Device: Gore® Viatorr® Endoprosthesis with controlled expansion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2020)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2026
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arineh Aghakhani 3102671268 aaghakhani@mednet.ucla.edu
Contact: Saima Chaabane 3107948995 schaabane@mednet.ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04315571
Other Study ID Numbers  ICMJE CXTIPSvLVP-v1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edward Wolfgang Lee, MD, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE W.L.Gore & Associates
Investigators  ICMJE
Principal Investigator: Edward W Lee, MD, PhD University of California
PRS Account University of California, Los Angeles
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP