Clinical research in hepatocellular carcinoma: study design and endpoints.

摘要

Surgical resection is an accepted treatment for hepatocellular carcinoma (HCC) [1]. However, its applicability is limited by several factors. In the large majority of cases, HCC develops in the context of underlying liver disease, usually in association with cirrhosis. Significant hepatic dysfunction or the presence of clinically relevant portal hypertension has a profound impact on the outcomes after resection. Consequently, the majority of patients with HCC will not be reasonable candidates for resection due to advanced liver disease. In addition, multifocality of the tumor as a result of intrahepatic metastases via microscopic invasion of the portal system often precludes curative resection and is also considered by many centers to be a contraindication to surgical resection. Well selected patients undergoing resection of HCC at an experienced center would be expected to have good outcomes with perioperative mortality below 3%, blood transfusion in less than 10% of cases, and 5-year survival rates of at least 50%