TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis
1 other identifier
interventional
153
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 1996
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 13, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedAugust 14, 2008
July 1, 2008
7.3 years
August 13, 2008
August 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival
10 years
Secondary Outcomes (1)
Control of bleeding and quality of life
10 years
Study Arms (2)
A
ACTIVE COMPARATORRandomization: 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.
B
ACTIVE COMPARATORProcedure: Emergency TIPS.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSD Medical Center
San Diego, California, 92103, United States
Related Publications (2)
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.
PMID: 24402314DERIVEDOrloff 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.
PMID: 23007280DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marshall J. Orloff, M.D.
UCSD Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 13, 2008
First Posted
August 14, 2008
Study Start
July 1, 1996
Primary Completion
October 1, 2003
Study Completion
July 1, 2006
Last Updated
August 14, 2008
Record last verified: 2008-07