Lygidakis 1996.
| Methods | Randomised. Generation of the allocation sequence: not clear. Allocation concealment: not clear. Blinding: no. Follow‐up: adequate. Intention‐to‐treat analysis: no, six post‐op (30 days) deaths excluded. Sample size calculations: no. | |
| Participants | 91 patients with hepatocellular carcinoma, tumour mass < 60% of liver surface, Okuda stage I or II, no extrahepatic disease. | |
| Interventions | 1. Surgery: 42 patients, hepatectomies and segmentectomies. 2. Neoadjuvant/Adjuvant: 49 participants. (i) 40 days preoperative (preoperative), chemoembolisation via portal vein with lipiodol 15 ml, urographin 5 ml, mitomycin C 0.2 mg/kg body wt (bw), carboplatin 0.5 mg/kg bw, Novantrone 0.8 mg/kg bw, gelfoam. (ii) 30 days preoperative, hepatic arterial chemotherapy with lipiodol 15 ml & urographin 5 ml emulsion of mitomycin C 0.2 mg/kg bw, carboplatin 1.5 mg/kg bw and Novantrone 0.2 mg/kg bw. (iii) 20 days preoperative, repeat of (ii). (iv) Surgery on day 40. (v) 1 month postoperative, hepatic arterial bolus chemotherapy with (ii), followed 15 days later by a 10‐day course of lipiodol 1.5 ml & urographin 0.5 ml emulsion of interleukin‐2 (Proleukin, Chiron) 1 ml, and gamma‐interferon 100 mcg 0.5 ml. (vi) Repeat of (v) every three months for first year, every four months for second year, every six months for third and fourth year. |
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| Outcomes | Follow‐up after each course with complete screening test. 1. Survival: survival curves. | |
| Notes | Groups comparable at baseline. Radicality of resection criteria not given. Quality of life measured, no details given. Adverse events were minimal and effectively treated with paracetamol or indomethacin. HR not reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |