Radiofrequency ablation using a 10-mm target margin for small hepatocellular carcinoma in patients with liver cirrhosis: A prospective randomized trial.

BACKGROUND AND OBJECTIVES

To compare 3-year clinical outcomes of radiofrequency ablation (RFA) targeting 5- or 10-mm margins for small hepatocellular carcinomas (HCCs) in cirrhotic patients.

METHODS

In total, 96 cirrhotic patients with a small solitary HCC (diameter ≤3 cm) were included in this prospective trial (ChiCTRTRC-10000954). Patients were stratified by Child-Pugh class and randomly allocated into groups targeting either wide margins (≥10 mm, WM) or narrow margins (≥5 mm but <10 mm, NM). RFA was performed under real-time monitoring, and ablative margins were evaluated by pre- and post-operative three-dimensional registration on CT.

RESULTS

The mean follow-up time was 38.3 ± 4.8 months, 83.3% (40/48) of patients succeeded in obtaining a 10-mm margin in WM group. Based on intention-to-treat analysis, the 3-year incidences of local tumor progression (LTP) (14.9% vs 30.2%), intrahepatic recurrence (IHR) (15.0% vs 32.7%), and recurrence-free survival (RFS) (31.7 ± 12.1 vs 24.0 ± 11.7 months) for WM group were significantly improved compared to NM group. Several prognostic factors were identified from univariate and multivariate analyses. Additionally, cirrhosis-stratified subgroup analyses demonstrated significant survival benefits of WM in patients with Child-Pugh class B cirrhosis.

CONCLUSIONS

RFA treatment targeting 10-mm margin may reduce the risk of tumor recurrence in cirrhotic patients with a single small HCC.