North American Study for the Treatment of Refractory Ascites (NASTRA)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Liver Cirrhosis; Ascites

Treatments: Procedure: Transjugular intrahepatic portasystemic shunts (TIPS); Procedure: Total paracentecis (TP)

Study type: Interventional

Funder types: NIH

Identifiers

NCT00006166

NASTRA (completed)

1R01DK051523 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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