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Erschienen in:
01.06.2013
Adjuvant Hepatic Intra-arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma: A Prospective Randomized Trial
Erschienen in: World Journal of Surgery | Ausgabe 6/2013
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Background
The purpose of the present study was to determine whether intrahepatic injection of 131I-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 131I-lipiodol and hepatic artery dissection during angiography.
Conclusions
The randomized trial provides insufficient evidence to recommend the routine use of 131I-lipiodol in these patients.