Wu 1995.
| Methods | Randomised. Generation of the allocation sequence: not clear Allocation concealment: not clear Blinding: no. Follow‐up: adequate. Intention‐to‐treat analysis: no. Sample size calculations: no. Not ITT, three postoperative deaths (within 30 days) excluded. | |
| Participants | 52 patients with large (diameter >= 10 cm) tumour, resectable (not diffuse bilobar, advanced cirrhosis, distant metastasis or main portal thrombi) and functional reserve ‐ Child's grade A or B. | |
| Interventions | 1. Surgery: 28 patients (classical or extended major hepatectomies for cirrhotics and Couinaud segment resection (Couinaud 1954) for non‐cirrhotics). 2. Neoadjuvant TACE: 24 patients, preoperative hepatic arterial infusion of doxorubicin 20 to 30 mg, lipiodol 20 to 30 ml and Spongostan film particles. Second course four to six weeks later, the number of courses per subject (max of six) decided on an individual basis. |
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| Outcomes | Follow‐up every three‐six months by AFP, CT, chest X‐ray, US. 1. Survival: survival curves for survival from time of tumour detection and from time of operation. 2. Disease‐free survival: survival curves. | |
| Notes | Groups comparable at baseline. Radicality of resection judged by histopathology, ˜50% patients <1cm disease‐free margin. Repeat TACE or resection was performed on patients with hepatic recurrence and systemic chemotherapy with 5‐fluorouracil, cisplatin, and doxorubicin on those with extrahepatic recurrence. Minor adverse events in 22 patients of adjuvant group ‐ fever, abdominal pain, upper gastrointestinal bleeding, transient ascites, acute cholecystitis. HR not reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |