San Diego Bleeding Esophageal Varices Study
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.
Survival and Control of Bleeding
Procedure: Emergency portacaval shunt
Procedure: Emergency and long-term endoscopic sclerotherapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||San Diego Bleeding Esophageal Varices Study|
- Survival [ Time Frame: 10 years ]
- Control of bleeding and quality of life [ Time Frame: 10 years ]
|Study Start Date:||April 1988|
|Study Completion Date:||December 2005|
|Primary Completion Date:||August 1996 (Final data collection date for primary outcome measure)|
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|
See attached Synopsis - APPENDIX 1
Please refer to this study by its ClinicalTrials.gov identifier: 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|