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 |