To assess the efficacy of the additional treatment of transcatheter arterial chemoembolization (TACE) to percutaneous ethanol injection (PEI) therapy for relatively small hepatocellular carcinomas (HCCs), a multicenter randomized control study (RCT) was performed. We conducted an RCT and follow-up study during the enrollment period from 1997 to 1999. Newly diagnosed patients with one to three HCC tumors measuring from 2 to 4 cm (4 cm maximum) in diameter were enrolled. A total of 30 patients initially underwent a combination TACE-PEI or PEI-alone therapies at eight randomly assigned Japanese hospitals. However, 3 patients withdrew. Of the 27 remaining patients, 13 were treated with the combination TACE-PEI therapy and 14 with PEI therapy alone. The patients were observed over several months [median (interquartile range) 33.2 (24.6) months]. There were no significant differences in the background of the patients between the two groups. Among the patients treated with TACE-PEI, the development of a local residual tumor was of significantly lower occurence, compared to the group receiving PEI alone (7.6 and 42.9%, respectively; P=0.024). However, the mean cancer-free time (absence of local or multiple nodule recurrence) or patient survival time was not significantly different between the two groups [PEI alone vs. TACE-PEI: cancer-free time 16.7 (95% CI 7.3-26.0) vs. 22.9 months (95% CI 12.4-33.4); survival time 57.2 (95% CI 37.2-77.2) vs. 42.4 months (95% CI 29.2-55.6)]. Although the combination of TACE and PEI had significant effects on the local tumor control, no efficacy of the addition of TACE to PEI was noted in the prognosis among patients with relatively small HCC tumors.

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