Adjuvant Hepatic Intra-arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma: A Prospective Randomized Trial

Background 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). Methods From June 2001 through March 2007, this nationwide multi-center prospective randomiz...

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Bibliographic Details
Published in:World journal of surgery 2013-06, Vol.37 (6), p.1356-1361
Main Authors: Chung, A. Y. F., Ooi, L. L. P. J., Machin, D., Tan, S. B., Goh, B. K. P., Wong, J. S., Chen, Y. M., Li, P. C. N., Gandhi, M., Thng, C. H., Yu, S. W. K., Tan, B. S., Lo, R. H. G., Htoo, A. M. M., Tay, K. H., Sundram, F. X., Goh, A. S. W., Chew, S. P., Liau, K. H., Chow, P. K. H., Tan, Y. M., Cheow, P. C., Ho, C. K., Soo, K. C.
Format: Article
Language:English
Subjects:
Abdominal Surgery
Aged
Antineoplastic Agents - therapeutic use
Carcinoma, Hepatocellular - drug therapy
Carcinoma, Hepatocellular - surgery
Cardiac Surgery
Chemotherapy, Adjuvant
Ethiodized Oil - therapeutic use
Female
Focal Nodular Hyperplasia
General Surgery
Health Science Authority
Humans
Injections, Intra-Arterial
Iodine Radioisotopes - therapeutic use
Liver Neoplasms - drug therapy
Liver Neoplasms - surgery
Male
Medicine
Medicine & Public Health
Middle Aged
Overall Survival
Prospective Studies
Surgery
Survival Rate
Thoracic Surgery
Transarterial Chemoembolization
Treatment Outcome
Vascular Invasion
Vascular Surgery
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Summary:Background 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). Methods 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. Results 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. Conclusions The randomized trial provides insufficient evidence to recommend the routine use of 131 I-lipiodol in these patients.
ISSN:0364-2313
1432-2323
DOI:10.1007/s00268-013-1970-4