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 Յ10 tumors all Յ5 cm in diameter (n ϭ 30) displayed 5-year recurrence rates (7.3%) similar to those of patients within the MC (9.7%, P ϭ 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 Յ10 tumors all Յ5 cm in diameter and protein induced by vitamin K absence or antagonist-II (PIVKA-II) Յ400 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 Ͻ 0.0001). Similarly, 5-year survival rates significantly differed between these groups (86.7% versus 34.4%, respectively; P Ͻ 0.0001). In conclusion, selection criteria for patients with HCC undergoing LDLT may be safely extended to Յ10 tumors all Յ5 cm in diameter and PIVKA-II Յ400 mAU/mL with acceptable outcomes. Liver Transpl 13: [1637][1638][1639][1640][1641][1642][1643][1644] 2007. © 2007 AASLD.Received April 3, 2007; accepted June 25, 2007. Orthotopic liver transplantation (OLT) has become widely accepted as the treatment of choice for early hepatocellular carcinoma (HCC). Among appropriately selected candidates, OLT for HCC provides excellent results, with overall survival rates exceeding 70%. [1][2][3] Mazzaferro et al. 1 reported that 48 patients with a single tumor Յ5 cm in diameter or with Յ3 tumors all Յ3 cm in diameter displayed survival rates comparable to those of non-HCC liver transplant recipients. These Milan criteria (MC) are currently widely accepted as an effective way of selecting patients with early-stage HCC for curative OLT.Conversely, because the MC were originally aimed at predicting good outcomes with low rates of recurrence, rather than poor outcomes with high recurrence rates, a substantial subset exists with the potential for good outcome after OLT among patients with HCC beyond the MC. In fact, many centers have performed OLT using extended criteria beyond the MC, showing acceptable overall and recurrence-free outcomes. [3][4][5][6][7][8][9] In particular, various rationales support the expansion of criteria for living donor liver transplantation (LDLT). First, in contrast to deceased donor liver transplantation (DDLT), which uses a scarce public resource subject to an equitable allocation system, living donor liver grafts are dedicated to related recipients. The acceptable recurrence rate is not absolute but rather depends on donor organ availability, and the value of LDLT for Abbreviations: AFP, ␣-fetoprotein; DDLT, deceased donor liver transplantation; GRWR, graft-to-recipient body weight ratio; HBV, hepatitis B virus; HCC, hepatocell...