2 Although several observational studies and suboptimal randomized controlled trials have demonstrated

that radiofrequency ablation (RFA) was comparable to HR with regard to the overall survival of patients with early stage HCC,3–9 learn more few comparative studies have been reported for very early stage HCC between HR and RFA. To obtain a definitive conclusion, it would be mandatory to perform a well-designed randomized trial concerning overall survival. However, an adequate randomized controlled trial would require enrollment of an enormous sample size of several thousands of patients. In this study, instead of performing a real randomized controlled trial, a simulated randomized trial was performed to compare the overall survival of compensated cirrhotic patients with very early stage HCC treated with HR, RFA, or the combined approach of primary RFA followed by HR for cases of initial local failure. HCC, hepatocellular carcinoma; HR, hepatic resection; RFA, radiofrequency ablation. We tried to compare HR and percutaneous RFA for the treatment of compensated cirrhotic patients with very early stage HCC by using a Markov model wherein the primary endpoint was overall survival. In this study, the presence of asymptomatic single HCC tumor <2 cm in the absence of portal vein invasion

or extrahepatic disease was defined as very early stage HCC according to the Barcelona Clinic Liver Cancer staging system.2 We created a multistate Markov model that simulated a randomized trial for the treatment of compensated cirrhotic patients with very early Protein Tyrosine Kinase inhibitor stage HCC. Each hypothetical patient was randomly assigned to undergo HR (group I), primary percutaneous RFA followed by HR for cases of initial local treatment failure (group II), or percutaneous RFA monotherapy

(group III), and 10,000 patients were allocated to each group. In group III, patients with initial tumor control failure did not undergo any further interventions and were transited to a state of progressive HCC. During the follow-up periods, all patients with recurrent HCC were considered candidates for RFA, regardless of the previous treatment modalities. For this Markov model, 14 states of health were defined, seven states for the find more cohort of patients undergoing HR and the remaining seven states for patients treated with RFA (Fig. 1). For each state of health, the probability of transition into other states was determined according to the values extracted from the literature (Table 1). In two Markov states, patients could stay longer than one cycle, which were a tumor-free state and progressive HCC state, respectively. The cycle length of the model was set to be 1 year. Half-cycle correction was used under the assumption that each transition happened halfway during the cycle.