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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Study Completion Date

2001-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ascites Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Transjugular intrahepatic portasystemic shunts (TIPS)

Intervention Type PROCEDURE

Total paracentecis (TP)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No