TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

University of California San Diego

Status: Completed

Conditions: Bleeding

Treatments: Procedure: Emergency portacaval shunt; Other: Emergency TIPS

Study type: Interventional

Funder types: Other

Identifiers

NCT00734227

TvSSTUDY

Details and patient eligibility

About

In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare the effectiveness in control of bleeding, mortality rate, duration of life, quality of life, and economic costs of two widely used treatment measures: (1) emergency transjugular intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.

Enrollment: 153 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with UGI bleeding who are shown to have the findings of cirrhosis and esophagogastric varices or portal hypertensive gastropathy and require 2 or more units of blood transfusion will be included.

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 2 patient groups

A

Active Comparator group

Description:

Randomization: By the blind card method to TIPS or emergency portacaval shunt. Diagnostic Workup: Completed within 6hr. Rapidity of Therapy: Within 24 hr. Failure of Therapy: Bleeding requiring \>6u PRBC in first 7 days, or 8 units PRBC during 12 months. Rescue Crossover Therapy: When primary therapy has failed. Followup: Lifelong data collection on line, analysis by biostatistician Florin Vaida, PhD. External Advisory, Data Monitoring and Safety Committee by 3 senior academicians. Procedure: Emergency portacaval shunt.

Treatment:

Procedure: Emergency portacaval shunt

B

Active Comparator group

Description:

Procedure: Emergency TIPS.

Treatment:

Other: Emergency TIPS