Trials / Completed
CompletedNCT00006166
North American Study for the Treatment of Refractory Ascites (NASTRA)
The North American Study for the Treatment of Refractory Ascites (NASTRA) Clinical Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transjugular intrahepatic portasystemic shunts (TIPS) | |
| PROCEDURE | Total paracentecis (TP) |
Timeline
- Start date
- 1997-03-01
- Completion
- 2001-10-01
- First posted
- 2000-08-09
- Last updated
- 2010-01-13
Locations
6 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00006166. Inclusion in this directory is not an endorsement.