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 longterm 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 will be randomized to either EPCS or EST. The diagnostic workup will be completed rapidly, EPCS or EST will be done within 8 hours of initial contact, and lifelong follow-up will be conducted in a special clinic. Treatment crossover (EPCS to EST, and EST to PCS) will be done only after primary treatment failure has been declared. The study will be monitored by an external Advisory Committee of senior scientists, and the data will be processed and analyzed by an external biostatistical firm with widely-recognized expertise in clinical trials. The study is unique in that it will be a community-vide endeavor in which 65 San Diego area physicians and two governmental hospitals will promptly refer patients with BEV to UCSD Medical Center for inclusion in the study. 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 should provide important information on the economic costs and benefits of these two forms of therapy.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
1R01DK041920-01A1
Application #
3242883
Study Section
Surgery and Bioengineering Study Section (SB)
Project Start
1990-07-15
Project End
1995-06-30
Budget Start
1990-07-15
Budget End
1991-06-30
Support Year
1
Fiscal Year
1990
Total Cost
Indirect Cost
Name
University of California Irvine
Department
Type
Schools of Medicine
DUNS #
161202122
City
Irvine
State
CA
Country
United States
Zip Code
92697
Orloff, Marshall J; Hye, Robert J; Wheeler, Henry O et al. (2015) Randomized trials of endoscopic therapy and transjugular intrahepatic portosystemic shunt versus portacaval shunt for emergency and elective treatment of bleeding gastric varices in cirrhosis. Surgery 157:1028-45
Orloff, Marshall J; Orloff, Mark S; Orloff, Susan L et al. (2014) Unshuntable extrahepatic portal hypertension revisited: 43 years' experience with radical esophagogastrectomy treatment of bleeding esophagogastric varices. Am J Surg 207:46-52
Orloff, Marshall J (2014) Fifty-three years' experience with randomized clinical trials of emergency portacaval shunt for bleeding esophageal varices in Cirrhosis: 1958-2011. JAMA Surg 149:155-69
Orloff, Marshall J; Isenberg, Jon I; Wheeler, Henry O et al. (2012) Disability index in a randomized controlled trial of emergency sclerotherapy versus portacaval shunt for bleeding varices in cirrhosis. Am J Surg 204:157-66
Orloff, Marshall J; Isenberg, Jon I; Wheeler, Henry O et al. (2012) A randomized controlled trial of emergency treatment of bleeding esophageal varices in cirrhosis for hepatocellular carcinoma. Am J Surg 203:182-90
Orloff, Marshall J; Vaida, Florin; Isenberg, Jon I et al. (2012) Child-Turcotte score versus MELD for prognosis in a randomized controlled trial of emergency treatment of bleeding esophageal varices in cirrhosis. J Surg Res 178:139-46
Orloff, Marshall J; Isenberg, Jon I; Wheeler, Henry O et al. (2012) Alcoholic versus nonalcoholic cirrhosis in a randomized controlled trial of emergency therapy of bleeding varices. J Surg Res 174:98-105
Orloff, Marshall J; Vaida, Florin; Haynes, Kevin S et al. (2012) Randomized controlled trial of emergency transjugular intrahepatic portosystemic shunt versus emergency portacaval shunt treatment of acute bleeding esophageal varices in cirrhosis. J Gastrointest Surg 16:2094-111
Orloff, Marshall J; Isenberg, Jon I; Wheeler, Henry O et al. (2011) Direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt for bleeding esophageal varices in cirrhosis--Part 4. J Gastrointest Surg 15:38-47
Orloff, M J; Isenberg, J I; Wheeler, H O et al. (2010) Liver transplantation in a randomized controlled trial of emergency treatment of acutely bleeding esophageal varices in cirrhosis. Transplant Proc 42:4101-8

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