Skip to main content
OpenTrials
Completed

NCT Number: NCT00006166

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ascites Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Toronto Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transjugular intrahepatic portasystemic shunts (TIPS)

Procedure

Total paracentecis (TP)

Procedure

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Official study title

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

Important dates

Study start
1997
Study completion
2001
First posted
Aug 9, 2000
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.