Gastroenterology

Gastroenterology

Volume 129, Issue 1, July 2005, Pages 122-130
Gastroenterology

Clinical-liver, pancreas, and biliary tract
A Randomized Controlled Trial of Radiofrequency Ablation With Ethanol Injection for Small Hepatocellular Carcinoma

https://doi.org/10.1053/j.gastro.2005.04.009Get rights and content

Background & Aims: Percutaneous radiofrequency ablation is a recently introduced treatment for hepatocellular carcinoma, whereas ethanol injection is now a standard therapy. We compared their long-term outcomes. Methods: Two hundred thirty-two patients with hepatocellular carcinoma who had 3 or fewer lesions, each 3 cm or less in diameter, and liver function of Child-Pugh class A or B were entered onto a randomized controlled trial. The primary end point was survival, and the secondary end points were overall recurrence and local tumor progression. Results: One hundred eighteen patients were assigned to radiofrequency ablation and 114 to ethanol injection. The number of treatment sessions was smaller (2.1 times vs 6.4 times, respectively, P < .0001) and the length of hospitalization was shorter (10.8 days vs 26.1 days, respectively, P < .0001) in radiofrequency ablation than in ethanol injection. Four-year survival rate was 74% (95% CI: 65%–84%) in radiofrequency ablation and 57% (95% CI: 45%–71%) in ethanol injection. Radiofrequency ablation had a 46% smaller risk of death (adjusted relative risk, 0.54 [95% CI: 0.33–0.89], P = .02), a 43% smaller risk of overall recurrence (adjusted relative risk 0.57 [95% CI: 0.41–0.80], P = .0009), and an 88% smaller risk of local tumor progression (relative risk, 0.12 [95% CI: 0.03–0.55], P = .006) than ethanol injection. The incidence of adverse events was not different between the 2 therapies. Conclusions: Judging from higher survival but similar adverse events, radiofrequency ablation is superior to ethanol injection for small hepatocellular carcinoma.

Section snippets

Eligibility Criteria

All patients diagnosed as having hepatocellular carcinoma at the Department of Gastroenterology, University of Tokyo, were candidates for enrollment. Inclusion criteria were (1) histopathologically confirmed carcinoma or a lesion showing characteristic imaging features of hepatocellular carcinoma, (2) lesions were unresectable or the patient had refused surgery, (3) 3 or fewer lesions, each 3 cm or less in diameter, (4) liver function of Child-Pugh class A or B, (5) no extrahepatic metastasis

Patients

Between April 1999 and January 2001, hepatocellular carcinoma was diagnosed in 507 patients. Among them, 232 (45.8%) patients met the eligibility criteria and agreed to take part in the study (Figure 1). Of the 275 patients excluded, 97 had more than 3 lesions, 92 had lesions over 3 cm in diameter, 71 were Child-Pugh class C, 8 had vascular invasion, 5 had extrahepatic metastasis, and 2 refused to take part, requesting ethanol injection. One hundred eighteen patients were assigned to

Discussion

This study demonstrated that radiofrequency ablation improves survival of patients with small hepatocellular carcinoma compared with ethanol injection. This result can probably be explained by the fact that radiofrequency ablation reduces overall recurrence and local tumor progression through its more reliable local antitumor effect. Actually, there was no statistical difference in the recurrence rates away from the original lesion between the 2 therapy groups (P = .560), and thus the

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    Supported in part by Grants-in-Aid from the Ministry of Education, Science, Sports, and Culture of Japan.

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    Copyright © 2005 American Gastroenterological Association. Published by Elsevier Inc. All rights reserved.