Partial hepatectomy with wide versus narrow resection margin for solitary hepatocellular carcinoma - A prospective randomized trial

Objective: To compare the efficacy and safety of partial hepatectomy aiming grossly at a narrow (1 cm) and a wide (2 cm) resection margin in patients with macroscopically solitary hepatocellular carcinoma (HCC). Summary Background Data: For HCC treated with partial hepatectomy, the extent of the margin of liver resection remains controversial despite extensive studies. Methods: We conducted a prospective randomized trial in patients with solitary HCC. From January 1999 to February 2003, 169 patients with solitary HCC were stratified according to tumor size and randomized to undergo partial hepatectomy aiming grossly at either a narrow (1 cm) (n=84) or a wide resection margin (2 cm) (n=85). Analyses were done on an intention-to-treat basis. Results: The demographic and pathologic data were similar in the 2 groups. The mean +/- SD for the final resection margin of the narrow and the wide margin groups were 0.7 +/- 0.4 cm and 1.9 +/- 0.6 cm, respectively. There was no significant difference in the morbidity and in-hospital mortality between the 2 groups of patients. The 1-, 2-, 3-, and 5-year overall survival rates for the narrow and the wide margin groups were 92.9%, 83.3%, 70.9%, and 49.1% and 96.5%, 91.8%, 86.9%, and 74.9%, respectively. The difference was significant (stratified log-rank test, P=0.008). Multivariate analysis identified the presence of micrometastases and the treatment allocation were independent risk factors for tumor-related death. At the time of censor, 75 (44.4%) patients had developed tumor recurrence. All recurrences at the margins of liver resection were observed in the narrow margin group. Multiple tumor recurrence was also significantly higher in the narrow margin group (chi(2) test, P=0.018). Survival after tumor recurrence was significantly better in the wide margin group than the narrow margin group (log-rank test, P=0.017). Conclusion: For macroscopically solitary HCC, a resection margin aiming grossly at 2 cm efficaciously and safely decreased postoperative recurrence rate and improved survival outcomes when compared with a gross resection margin aiming at 1 cm, especially for HCC <= 2 cm.