Percutaneous radiofrequency ablation of hepatocellular carcinoma compared to percutaneous ethanol injection in treatment of cirrhotic patients: an Italian randomized controlled trial.

AIM: To compare 5-year survival of patients with a single hepatocellular carcinoma≤3 cm randomly assigned to receive percutaneous ethanol injection or radiofrequency ablation. PATIENTS AND METHODS: A total of 285 patients (192 males, mean age 70 years), with a single hepatocellular carcinoma (mean diameter 2.2 cm) were randomly assigned to receive percutaneous ethanol injection (n=143) or radiofrequency ablation (n=142). The primary endpoint of the study was 5-year survival. RESULTS: Overall 143 patients underwent percutaneous ethanol injection and 128 radiofrequency ablation. In consideration of segmental location, in fact, 14 patients with 14 hepatocellular carcinomas could not be treated with established radiofrequency and were treated with percutaneous ethanol injection; these patients were not included in the survival evaluation. In the percutaneous ethanol injection and in the radiofrequency ablation groups, 3- and 5-year survival rates of 74% and 68%, and 78% and 68%, and 79% and 70% [corrected] respectively, were observed (p=n.s). In the percutaneous ethanol injection group, 3- and 5-year local recurrence rates were 9.4% and 12.8% respectively; in the radiofrequency group, the 3 and 5 years local recurrence rates were 7.8% and 11.7%, respectively (p=n.s.). The overall costs of percutaneous ethanol injection and radiofrequency ablation were 1359 Euros and 171.000 Euros, respectively (p<0.0001) CONCLUSION: Percutaneous ethanol injection and radiofrequency ablation conferred similar 5-year survival. Feasibility is not the same for both procedures. Percutaneous ethanol injection is much cheaper than radiofrequency ablation and should be considered whether in poor and rich countries.