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 : May 12, 2023
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|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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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, 2024|
|Estimated Study Completion Date :||January 1, 2026|
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
- Number of Paracentesis [ Time Frame: 1 year post-procedure ]The average number of paracentesis per week.
- Transplant free survival [ Time Frame: 1 year post-procedure or until the patient expires or receives transplant ]Overall survival without transplant after the treatment
- Stent diameter change [ Time Frame: 1 month and 6 months ]Stent diameter changes from the time of TIPS placement
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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)).
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
|Contact: Saima C Chaabane, PhDemail@example.com|
|Contact: Saima Chaabanefirstname.lastname@example.org|
|United States, California|
|UCLA Medical Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Principal Investigator: Edward W Lee, M.D.|
|Principal Investigator:||Edward W Lee, MD, PhD||University of California|
|Responsible Party:||Edward Wolfgang Lee, MD, Associate Professor of Radiology and Surgery, University of California, Los Angeles|
|Other Study ID Numbers:||
|First Posted:||March 19, 2020 Key Record Dates|
|Last Update Posted:||May 12, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|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|
end-stage liver disease
Digestive System Diseases