Lai 1998.
| Methods | Randomised. Generation of the allocation sequence: not clear. Allocation concealment: sealed envelopes. Blinding: no. Follow‐up: adequate. Intention‐to‐treat analysis: yes. Sample size calculations: yes. | |
| Participants | 76 patients (53 men and 13 women, mean age 53.3 years (range 28 to 78 years)), without residual disease by imaging 1 month after curative resection. | |
| Interventions | 1. Surgery: 36 patients by referenced technique (Lai 1995) . 2. Adjuvant: 30 patients, six‐eight weeks postoperative systemic chemotherapy of IV epirubicin 40 mg/m twice at six‐week intervals (max eight courses). Additionally, three bimonthly courses of slow hepatic arterial infusion chemotherapy using iodised oil 10 ml and cisplatin 10 mg either via a subcutaneous port or femoral artery catheterization. |
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| Outcomes | 1. Survival: survival curves from day of operation. 2. Diseases‐free survival: survival curves from day of operation. | |
| Notes | Groups comparable at baseline. Radicality of resection judged by US, angiography and histopathology, all randomised were negative for disease one month after surgery. Adverse events in six patients in adjuvant group, three had local complications (extravasation cellulitis (2), severe epigastric pain and gastric necrosis) after TACE with subcutaneous port and three others with atrial fibrillation, leukopenia, and alopecia. Frequency and manner of follow‐up not described. TACE, systemic chemotherapy and resection were performed on 40 patients with recurrence. Sample size calculation based on recurrence rate at 3rd postoperative year of 70% (surgery) versus 35% (adjuvant) with 5% type I error and 20% type II error (2‐tailed). No HRs reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | A ‐ Adequate |