Adjuvant hepatic intra-arterial iodine-131-lipiodol following curative resection of hepatocellular carcinoma: a prospective randomized trial

Autor: A. Y. F. Chung, L. L. P. J. Ooi, D. Machin, S. B. Tan, B. K. P. Goh, J. S. Wong, Y. M. Chen, P. C. N. Li, M. Gandhi, C. H. Thng, S. W. K. Yu, B. S. Tan, R. H. G. Lo, A. M. M. Htoo, K. H. Tay, F. X. Sundram, A. S. W. Goh, S. P. Chew, K. H. Liau, P. K. H. Chow, Y. M. Tan, P. C. Cheow, C. K. Ho, K. C. Soo
Rok vydání: 2013
Předmět:
Zdroj: World journal of surgery. 37(6)
ISSN: 1432-2323
Popis: The purpose of the present study was to determine whether intrahepatic injection of (131)I-lipiodol (Lipiodol) is effective against recurrence of surgically resected hepatocellular carcinoma (HCC).From June 2001 through March 2007, this nationwide multi-center prospective randomized controlled trial enrolled 103 patients 4-6 weeks after curative resection of HCC with complete recovery (52: Lipiodol, 51: Control). Follow-up was every 3 months for 1 year, then every 6 months. Primary and secondary endpoints were recurrence-free survival (RFS) and overall survival (OS), respectively, both of which were evaluated by the Kaplan-Meier technique and summarized by the hazard ratio (HR). The design was based on information obtained from a similar trial that had been conducted in Hong Kong.The Lipiodol group showed a small, and nonsignificant, improvement over control in RFS (HR = 0.75; 95 % confidence interval [95 % CI] 0.46-1.23; p = 0.25) and OS (HR = 0.88; 95 % CI 0.51-1.51; p = 0.64). Only two serious adverse events were reported, both with hypothyroidism caused by (131)I-lipiodol and hepatic artery dissection during angiography.The randomized trial provides insufficient evidence to recommend the routine use of (131)I-lipiodol in these patients.
Databáze: OpenAIRE