Radiofrequency ablation versus ethanol injection for early hepatocellular carcinoma: A randomized controlled trial.
OBJECTIVE
To compare percutaneous ethanol injection (PEI), the standard approach which has been used for many years to treat early non-surgical hepatocellular carcinoma (HCC) in cirrhotic patients, and radiofrequency ablation (RFA), which has become an interesting alternative.


METHODS
A randomized trial was carried out on 139 cirrhotic patients in Child-Pugh classes A/B with 1-3 nodes of HCC (diameter 15-30 mm), for a total of 177 lesions. Patients were randomized to receive RFA (n=70) or PEI (n=69). The primary end-point was complete response (CR) 1 year after the percutaneous ablation of all HCC nodes identified at baseline. Secondary end-points were: early (30-50 days) CR, complications, survival and costs.


RESULTS
In an intention-to-treat analysis, 1-year CR was achieved in 46/70 (65.7%) and in 25/69 (36.2%) patients treated by RFA and PEI, respectively (p=0.0005). For lesions >20 mm in diameter, there was a larger CR rate in the RFA group (68.1% versus 26.3%). An early CR was obtained in 67/70 (95.7%) patients treated by RFA compared with 42/64 (65.6%) patients treated by PEI (p=0.0001). Complications occurred in 10 and 12 patients treated by RFA and PEI, respectively. The overall survival rate was not significantly different in the RFA versus PEI arm (adjusted hazard ratio=0.88, 95% CI: 0.50-1.53). There was an incremental health-care cost of 8286 euro for each additional patient successfully treated by RFA.


CONCLUSIONS
The 1-year CR rate after percutaneous treatment of early HCC was significantly better with RFA than with PEI but did not provide a clear survival advantage in cirrhotic patients.
Brunello
Franco
F
Divisione di Gastro-Epatologia, Ospedale San Giovanni Battista di Torino, Turin, Italy. francobrunello@libero.it
Veltri
Andrea
A
Carucci
Patrizia
P
Pagano
Eva
E
Ciccone
Giovannino
G
Moretto
Paolo
P
Sacchetto
Paola
P
Gandini
Giovanni
G
Rizzetto
Mario
M
D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000191:economics / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D017115:Catheter Ablation / Q000009:adverse effects / Q000191:economics; D000431:Ethanol / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D005260:Female; D006801:Humans; D015552:Injections, Intralesional; D008113:Liver Neoplasms / Q000191:economics / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D008297:Male; D015996:Survival Rate
D000431:Ethanol