San Diego Bleeding Esophageal Varices Study

Study Overview
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Brief Summary
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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.

Detailed Description
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See attached Synopsis - APPENDIX 1

Official Title
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San Diego Bleeding Esophageal Varices Study

Conditions
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Survival and Control of Bleeding

Intervention / Treatment
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* Procedure: Emergency portacaval shunt
* Procedure: Emergency and long-term endoscopic sclerotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with UGI bleeding (blood in the esophagus, stomach, or duodenum) who enter the emergency room or develop bleeding while in the hospital or are transferred from nearby hospitals and are suspected of having cirrhosis and BEV will be eligible for consideration (all comers). Those who are shown to have the findings of cirrhosis and esophageal varices that: Are seen to be actively bleeding; Have an adherent clot; Have no other associated lesion that could reasonably account for bleeding of that magnitude (such as large gastric or duodenal varices, GU, DU, etc) Require 2 or more units of blood transfusion, will be included in the study. Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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<br> <br> |
| Active Comparator: B<br>Emergency endoscopic sclerotherapy | Procedure: Emergency and long-term endoscopic sclerotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of bleeding and quality of life |  | 10 years |