Ascites, Liver Cirrhosis
Conditions
Keywords
refractory ascites, paracenteses
Brief summary
The NASTRA Clinical Trial is a multi-center, randomized, controlled clinical trial designed to determine if treatment with transjugular intrahepatic portasystemic shunts (TIPS) is superior to high volume paracentesis (total paracentesis, TP) for the treatment of refractory ascites due to cirrhosis. Only patients with clinically tense symptomatic ascites (shortness of breath, umbilical hernia, abdominal pain and/or distension, and/or limitation of activity) who have either diuretic-resistant ascites or diuretic-intractable ascites are being studied.
Interventions
PROCEDURETransjugular intrahepatic portasystemic shunts (TIPS)
PROCEDURETotal paracentecis (TP)
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Cirrhosis as documented by biopsy or clinical/laboratory parameters WITH * Tense symptomatic ascites and need for paracentesis (10 L) within last 2 months AND * Failure of medical therapy as defined by the inability to lose at least 3.3 lbs/week while on maximum doses of diuretics or diuretic related complications (severe hyponatremia, hypercalcemia, azotemia or encephalopathy)
Exclusion criteria
* Causes of ascites other than cirrhosis and portal hypertension * Terminal liver failure * Portal vein thrombosis * Congestive heart failure * Acute renal failure * Active encephalopathy * Alcoholic hepatitis * Pregnancy
Countries
Canada, United States
Outcome results
None listed