Comparing Ascites Relief In Two Standard Treatments: Large Volume

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04315571
Study type	Interventional
Source	University of California, Los Angeles
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 24, 2020
Completion date	January 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02891642` - Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
Recruiting	`NCT00239096` - Prevention of Decompensation in Liver Cirrhosis	Phase 4
Active, not recruiting	`NCT03973866` - Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)	N/A
Terminated	`NCT01455246` - Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis	Phase 2/Phase 3
Completed	`NCT01349348` - Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites	Phase 3
Completed	`NCT01578226` - Procalcitonin in Cirrhotic Patients at High Risk for Sepsis	N/A
Terminated	`NCT00548366` - Sodium Restriction in the Management of Cirrhotic Ascites	Phase 4
Recruiting	`NCT05025878` - 13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.
Completed	`NCT03327688` - Point-of-care Ultrasound in Finland	N/A
Not yet recruiting	`NCT04550091` - Role Of Multi-detector Computed Tomography In Differentiation Between Different Types Of Ascites
Not yet recruiting	`NCT01716611` - Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites	Phase 4
Completed	`NCT01769040` - Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With Cirrhosis	Phase 4
Recruiting	`NCT05700708` - Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
Recruiting	`NCT05511766` - Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis	Phase 2/Phase 3
Completed	`NCT05013502` - Empagliflozin in Diuretic Refractory Ascites	Phase 1
Not yet recruiting	`NCT06436807` - PMCF Study of the CE-marked Drainova® ArgentiC Catheter
Completed	`NCT03263598` - Validation of Diagnostic Usefulness of the Random Urine Na/K Ratio for Replacement of 24hr Urine Na Excretion in Cirrhotic Patients With Ascites
Completed	`NCT00907673` - The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure	N/A
Terminated	`NCT00796861` - Trial of Sunitinib for Refractory Malignant Ascites	Phase 2
Suspended	`NCT00511394` - Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms