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

NCT00006166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2010-01-13

No results posted yet for this study

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

PROCEDURE

Transjugular intrahepatic portasystemic shunts (TIPS)

PROCEDURE

Total paracentecis (TP)

Sponsors & Collaborators

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

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-03-31
Completion
2001-10-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006166 on ClinicalTrials.gov