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Procedure
San Diego Bleeding Esophageal Varices Study
N/A
Waitlist Available
Led By Marshall J Orloff, M.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Hemostasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: AActive Control1 Intervention
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.
Group II: BActive Control1 Intervention
Emergency endoscopic sclerotherapy
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,497 Total Patients Enrolled
Marshall J Orloff, M.D.Principal InvestigatorUCSD Medical Center
1 Previous Clinical Trials
518 Total Patients Enrolled