Yunxue 1999.
| Methods | Randomised. Generation of the allocation sequence: not clear. Allocation concealment: no. Blinding: no. Follow‐up: adequate. Intention‐to‐treat analysis: yes. Sample size calculations: no. | |
| Participants | TACE group: 29 male and 3 female patients with a mean age of 44.2 years. Alpha‐Fetoprotein was > 200ng/ml in 22 patients and < 200 ng/ml in 10 patients. Tumour size was >10 cm in 14 patients, 5 to 10 cm in 14 patients and < 5 cm in 4 patients. Surgery Alone: 31 male and 4 female patients with a mean age of 46.3 years. Alpha‐Fetoprotein was > 200ng/ml in 25 patients and < 200 ng/ml in 10 patients. Tumour size was >10 cm in 9 patients, 5 to 10 cm in 22 patients and < 5 cm in 4 patients. |
|
| Interventions | 1. Surgery: 35 patients were operated. 2. Adjuvant: 32 patients were given preoperative transcatheter hepatic arterial chemoembolisation with MMC1‐10mg, 5Fu50 to 2000mg, EPIR 6 to 10mg, Carboplatin 300 to 500 mg; either in combination of 2 or 3 treatments. |
|
| Outcomes | Recurrence at original site; Recurrence at other sites; Time to recurrence; Two‐year survival rate. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |
AFP = alpha‐fetoprotein. CT = computerised tomography. HCFU = 1‐hexylcarbamoyl 5‐fluorouracil. HR ‐ hazard ratio. ICG‐R15 ‐ Indocyanin Green 15 min retention rate. ITT ‐ intention‐to‐treat. TACE ‐ transcatheter arterial chemoembolisation. US ‐ ultrasonography.