In the present study, the results of living donor liver transplantation (LDLT) for 125 hepatocellular carcinoma (HCC) patients were analyzed to determine optimal criteria exceeding the Milan criteria (MC) but still with predictably good outcomes. On the basis of pretransplant imaging studies, 70 patients met the MC, and 55 patients did not. Patients who exceeded the MC but presented with <or=10 tumors all<or=5 cm in diameter (n=30) displayed 5-year recurrence rates (7.3%) similar to those of patients within the MC (9.7%, P=0.8787). According to the results of multivariate analysis of risk factors for recurrence among preoperative tumor variables, we have defined the new criteria, namely <or=10 tumors all<or=5 cm in diameter and protein induced by vitamin K absence or antagonist-II (PIVKA-II)<or=400 mAU/mL. The 78 patients who met the new criteria showed significantly lower 5-year recurrence rates (4.9%) than the 40 patients who exceeded them (60.5%, P<0.0001). Similarly, 5-year survival rates significantly differed between these groups (86.7% versus 34.4%, respectively; P<0.0001). In conclusion, selection criteria for patients with HCC undergoing LDLT may be safely extended to <or=10 tumors all<or=5 cm in diameter and PIVKA-II<or=400 mAU/mL with acceptable outcomes.
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