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TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

NCT ID: NCT00734227

Last Updated: 2008-08-14

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

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-07-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bleeding

Keywords

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Survival and control of hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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A

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.

Group Type ACTIVE_COMPARATOR

Emergency portacaval shunt

Intervention Type PROCEDURE

B

Procedure: Emergency TIPS.

Group Type ACTIVE_COMPARATOR

Emergency TIPS

Intervention Type OTHER

Interventions

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Emergency portacaval shunt

Intervention Type PROCEDURE

Emergency TIPS

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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University of California, San Diego

Principal Investigators

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Marshall J. Orloff, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCSD Medical Center

Locations

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UCSD Medical Center

San Diego, California, United States

Site Status

Countries

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United States

References

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Orloff MJ. Fifty-three years' experience with randomized clinical trials of emergency portacaval shunt for bleeding esophageal varices in Cirrhosis: 1958-2011. JAMA Surg. 2014 Feb;149(2):155-69. doi: 10.1001/jamasurg.2013.4045.

Reference Type DERIVED
PMID: 24402314 (View on PubMed)

Orloff MJ, Vaida F, Haynes KS, Hye RJ, Isenberg JI, Jinich-Brook H. Randomized controlled trial of emergency transjugular intrahepatic portosystemic shunt versus emergency portacaval shunt treatment of acute bleeding esophageal varices in cirrhosis. J Gastrointest Surg. 2012 Nov;16(11):2094-111. doi: 10.1007/s11605-012-2003-6. Epub 2012 Sep 25.

Reference Type DERIVED
PMID: 23007280 (View on PubMed)

Other Identifiers

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TvSSTUDY

Identifier Type: -

Identifier Source: org_study_id