San Diego Bleeding Esophageal Varices Study
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|ClinicalTrials.gov Identifier: NCT00690027|
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : June 4, 2008
In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of:
- Emergency portacaval shunt, and
- Emergency and long-term endoscopic sclerotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Survival and Control of Bleeding||Procedure: Emergency portacaval shunt Procedure: Emergency and long-term endoscopic sclerotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||San Diego Bleeding Esophageal Varices Study|
|Study Start Date :||April 1988|
|Actual Primary Completion Date :||August 1996|
|Actual Study Completion Date :||December 2005|
Active Comparator: A
Objective: See Brief Summary, page 2. Eligibility: Patients who require > 2 units blood transfusion for bleeding esophageal varices due to cirrhosis.
Randomization: By the blind card method to emergency portacaval shunt (EPCS) or emergency endoscopic sclerotherapy (EST) followed by long-term repetitive EST.
Diagnostic Workup: Completed within 6hr. Rapidity of Therapy: Within 8hr. Failure of Therapy: Bleeding requiring >6u PRBC in first 7 days, or 8 units PRBC during 12 months, or rebleeding after varices were obliterated.
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
Active Comparator: B
Emergency endoscopic sclerotherapy
Procedure: Emergency and long-term endoscopic sclerotherapy
- Survival [ Time Frame: 10 years ]
- Control of bleeding and quality of life [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690027
|United States, California|
|200 West Arbor Drive|
|San Diego, California, United States, 92103-8999|
|Principal Investigator:||Marshall J Orloff, M.D.||UCSD Medical Center|