[Randomized clinical trial of percutaneous radiofrequency ablation plus absolute ethanol injection compared with radiofrequency ablation alone for small hepatocellular carcinoma].

OBJECTIVE: To compare percutaneous radiofrequency ablation (RFA) alone and RFA combined with percutaneous absolute ethanol injection (RFA-PEI) in the treatment of single hepatocellular carcinoma smaller than 5.0 cm in diameter.

METHODS: From Jan. 2002 till Dec. 2003, eighty-six patients were put on a randomized clinical trial. For RFA, the American Radiotherapeutics RF 2000 machine and 3.5 cm/LEE VEEN + electroradiofrequency needle was introduced under ultra-beta sound guide. For tumor < 3 cm, the needle was left in center of tumor and for tumor > 3 cm, the needle was first left in situ and twisted by 180 as it was withdrawn for every 1 cm, till the surface border was reached. Power output was increased from 20 W and raised by 10-20 W per minute until the impedance became rapidly raised and the output decreased. Forty-five patients were treated with RFA-PEI and 41 with RFA, with each group divided into group A (diameter < or = 3.0 cm) and group B (diameter = 3.1-5.0 cm) according to tumor size. The overall and local recurrence-free survival was used to evaluate the treatment effect.

RESULTS: There was no mortality or serious morbidity in either group. The 6-, 12-, 18-, 24-month survival rate of RFA-PEI and RFA was 88.9%, 84.0%, 80.6%, 73.9% and 87.7%, 78.3%, 73.7%, 61.4% (P = 0.6181), respectively; and the local recurrence-free survival rates was 95.4%, 95.4%, 87.8%, 73.7% and 94.9%, 72.7%, 68.4%, 57.1% (P = 0.0393), respectively. The local recurrence-free survival rate in group A was 95.7%, 95.7%, 79.1%, 79.1% and 92.3%, 83.2%, 81.3%, 65.9% (P = 0.3679), respectively; while in group B was 95.0%, 95.0%, 95.0%, 72.6% and 100.0%, 58.3%, 45.4%, 45.4% (P = 0.0440).

CONCLUSION: Percutaneous radiofrequency ablation combined with percutaneous absolute ethanol injection is safe, and more effective and easily practiced than percutaneous radiofrequency ablation alone in the treatment of small hepatocellular carcinoma, especially when the tumor is greater than 3 cm in diameter, for which RFA-PEI may be able to reduce local recurrence and improve long-term survival.