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

Izumi 1994.

Methods Randomised. 
 Generation of the allocation sequence: not clear. 
 Allocation concealment: not clear. 
 Blinding: no. 
 Follow‐up: adequate. 
 Intention‐to‐treat analysis: no. Two patients originally randomised to the adjuvant group seem to have been reallocated to the surgery group. 
 Sample size calculations: no.
Participants 50 patients with invasive Hepatocellular Carcinoma with vascular invasion and/or intrahepatic metastasis diagnosed by computed tomography (CT), and ultrasonography (US).
Interventions (1) Surgery: 25 patients randomised, but 27 treated by lobectomy, sub‐ and segmentectomy, and major wedge resection.
(2) Adjuvant: 25 patients randomised, but 23 treated, hepatic arterial bolus infusion 21 to 84 days postoperatively (postop) (mean 38.4) either by (a) transcatheter arterial chemoembolisation (TACE) for 7 patients with good liver function (hepaplastin > 60%) lipiodol 3 ml/m2, doxorubicin 20 mg/m2, mitomycin C 10 mg/m2 followed by gelatin sponge cubes (Gelfoam, Upjohn) or (b) chemotherapy without embolisation for the remaining 16 patients, lipiodol 2 ml/m2, doxorubicin 20 mg/m2, mitomycin C 10 mg/m2.
Outcomes Follow‐up bimonthly for first year and hence every three‐monthly by alpha‐fetoprotein (AFP), US, CT, angiography. 
 1. Survival: survival curves. 
 2. Disease‐free survival: survival curves.
Notes Groups comparable at baseline. 
 Radicality of resection judged by intraoperative US, all macroscopic tumour removed, no histopathology discussed. 
 Transient fever or nausea after adjuvant therapy. 
 Repeat TACE, systemic chemotherapy and resection were performed on patients with recurrence. 
 Hazard ratio (HR) not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear