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| Name | Class |
|---|---|
| W.L.Gore & Associates | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Routine Large Volume Paracentesis (LVP) with albumin infusion |
|
| Group B | Active Comparator | Early Transjugular intrahepatic portosystemic shunt (TIPS) procedure using Gore Viatorr CX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gore® Viatorr® Endoprosthesis with controlled expansion | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Paracentesis | The average number of paracentesis per week. | 1 year post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival | Overall survival without transplant after the treatment | 1 year post-procedure or until the patient expires or receives transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Stent diameter change | Stent diameter changes from the time of TIPS placement | 1 month and 6 months |
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward W Lee, MD, PhD | University of California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38235907 | Derived | Gonzalez-Garay AG, Serralde-Zuniga AE, Velasco Hidalgo L, Flores Garcia NC, Aguirre-Salgado MI. Transjugular intrahepatic portosystemic shunts for adults with hepatorenal syndrome. Cochrane Database Syst Rev. 2024 Jan 18;1(1):CD011039. doi: 10.1002/14651858.CD011039.pub2. |
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| Large Volume Paracentesis with albumin infusion | Procedure | 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. |
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|
| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D001201 | Ascites |
| D058625 | End Stage Liver Disease |
| D006501 | Hepatic Encephalopathy |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019168 | Portasystemic Shunt, Transjugular Intrahepatic |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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