Bleeding esophageal varices (BEV) due to cirrhosis is a common and highly lethal condition that is characterized by recurrent hemorrhage and early death in the majority of patients. Many types of therapy have been used for BEV, but it is not known which one is best and none has been shown unequivocally to improve long-term survival. The objective of the proposed study is to compare two widely used therapeutic modalities, emergency portacaval shunt (EPCS) and emergency and long-term endoscopic sclerotherapy (EST), with regard to (a) mortality rate, (b) duration of life, (c) quality of life, (d) direct and indirect economic costs, and (e) treatment failure, defined precisely in terms of number of blood transfusions required because of recurrent BEV. Unselected patients (""""""""all comers"""""""") with BEV due to cirrhosis are randomized to either EPCS or EST. The diagnostic workup is completed rapidly, EPCS or EST is done within 8 hours of initial contact, and lifelong follow-up is conducted in a special clinic. Treatment crossover (EPCS to EST, and EST to PCS) is done only after primary treatment failure has been declared. The study is being monitored by an External Advisory Committee of senior scientists, and the data are being processed and analyzed by an external biostatistical firm with widely-recognized expertise in clinical trials. The study is unique in that it is a community-wide endeavor in which 130 San Diego area physicians promptly refer patients with BEV to UCSD Medical Center for inclusion in the study. To date 132 patients have been entered. What remains is to complete the accrual of the target number of 160-170 patients, complete long-term EST, complete follow-up evaluations, perform a quality of life survey, and analyze the large amount of data that has been collected. By clearly determining the most effective treatment of BEV, the results of this study should have substantial impact on the survival and quality of life of the bleeding cirrhotic population, and will provide important information on the economic costs and benefits of these two forms of therapy.
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