Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma
Local ablation is a safe and effective therapy for patients who cannot undergo resection, or
as a bridge to transplantation. Of the various percutaneous local ablative therapies,
radiofrequency ablation (RFA) has attracted the greatest interest because of its
effectiveness and safety for small HCC ≤ 5.0cm, with a 3-year survival rate of 62% to 68%, a
low treatment morbidity of 0% to 12%, and a low treatment mortality of 0% to 1%. Prospective
randomized trials have shown RFA to be better than percutaneous ethanol injection (PEI) in
producing a higher rate of complete tumor necrosis with fewer numbers of treatment sessions
and better survival.
Unfortunately, the complete tumor necrosis rate for tumors larger than 5cm is less
favorable, and the local recurrence rate can be as high as 20% even in small HCC less than
3.5cm. The high local recurrence rate may be due to residual cancer cells not killed by RFA
or adjacent microscopic satellite tumor nodules.
Transcatheter Arterial Chemoembolization (TACE) is proved to be an effective and palliative
therapy for unresectable HCC. And some studies showed that combined TACE and RFA may produce
superior tumor control than RFA alone and reduce local recurrence rate. In a study by
Yamakado et al., 64 patients with 92 tumors underwent RFA within two weeks after TACE. The
intrahepatic recurrence rates were 15% at 1 year and 43% at 2years, the 1, and 2, year
overall survivals were 100% and 93%, respectively. These results appeared favorable, but
there has not a prospective randomized controlled study to compare RFA combine with TACE
versus RFA alone.
Thus the purpose of our study was to prospectively evaluate whether combined RFA and TACE
(RFA-TACE) result in better survival outcomes than RFA alone in patients with HCC.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Overall Survival
3, 5 years
No
Min-Shan Chen, Doctor
Principal Investigator
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
China: Ministry of Health
rfa-001
NCT00554905
October 2006
June 2009
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