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. 2009 Jan 21;2009(1):CD001199. doi: 10.1002/14651858.CD001199.pub2

Yamasaki 1996.

Methods Randomised. 
 Generation of the allocation sequence: not clear. 
 Allocation concealment: sealed envelopes. 
 Blinding: no. 
 Follow‐up: adequate. 
 Intention‐to‐treat analysis: 18 patients (seven surgery, 11 adjuvant) excluded. 
 Sample size calculations: no.
Participants 115 male patients, <= 65 years with resectable hepatocellular carcinoma tumours from 2 to 5 cm in diameter diagnosed by imaging modalities, without severe cirrhosis, Indocyanin Green 15 min retention time (ICG R15) < 40%, serum bilirubin <=1.5 mg/ml, Okuda stage I.
Interventions 1. Surgery: 58 patients randomised, but 47 treated by limited resection, sub‐ and segmentectomy and lobectomy.
2. Adjuvant TACE: 57 patients randomised, but 50 treated, preoperative hepatic arterial infusion of doxorubicin 20 mg in urografin 2.5 ml and lipiodol 5 ml followed by gelatin sponge cubes 1 to 3 mm in urografin.
Outcomes 1. Survival: survival curves and five‐year survival rate. 
 2. Disease‐free survival: survival curves and 5‐yr disease‐free survival rate.
Notes Groups comparable at baseline. 
 Radicality of resection judged by histopathology, no data given. 
 Frequency or manner of follow‐up not reported. 
 No discussion of adverse events. 
 HR not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate