Aim: To conduct a randomized trial to evaluate the role of using high-dose iodized oil transcatheter arterial chemoembolization (TACE) in the treatment of large hepatocellular carcinoma (HCC).
Methods: From January 1993 to June 1998, 473 patients with unresectable hepatocellular carcinoma were divided into two groups: 216 patients in group A received more than 20 mL iodized oil during the first TACE treatment; 257 patients in group B received 5-15 mL iodized oil in the same way. The Child's classification and ICG-R15 for evaluating the liver function of the patients were done before the treatment. During the TACE procedure the catheters were inserted into the target artery selectively and the tumor vessels were demonstrated with contrast medium in the hepatic angiography.The anticancer drugs mixed with iodized oil (Lipiodol) were Epirubicin and Mitomycin. In group A, 112 cases received 20-29 mL Lipiodol in the first procedure, 85 cases 30-39 mL, 19 cases more than 40 mL. The largest dose was 53 mL and the average dose was 28.3 mL. In group B, 119 cases received 5-10 mL Lipiodol,138 cases received 11-15 mL and the average dose was 11.8 mL.
Results: High-dose Lipiodol chemoembolization had tolerable side effects and a little hurt to the liver function in the patients with Child's A or ICG-R15<20. But the patients with child's B or ICG-R15>20 had higher risk of liver failure after high-dose TACE. More type I and type II in CT scan after 4 weeks of TACE were seen in the patients of group A than those in the patients of group B (P<0.01). The resection rate and complete tumor necrosis rate of group A were higher than those of group B (P<0.05). The 1-,2-, 3-year survival rates of group A patients with Child's A were 79.2 , 51.8 and 34.9 , respectively, better than those of group A (P<0.001).
Conclusion: High-dose Lipiodol can result in more complete tumor necrosis by blocking both arteries and small portal vein of the tumor. High-dose TACE for treatment of large and hypervascular hepatocellular carcinoma is practically acceptable with the better effect than the routine dose. For the patients with large and hypervascular tumor of Child grade A liver function or ICG-R15 less than 20%, oily chemoembolization with 20-40 mL Lipiodol is recommended.