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. 2017 Mar 28;2017(3):CD011650. doi: 10.1002/14651858.CD011650.pub2

Gan 2004.

Study characteristics
Methods Randomised clinical trial
Participants Country: China
Number randomised: 38
Postrandomisation dropouts: 11 (28.9%)
Revised sample size: 27
Average age: 53 years
Females: 3 (11.1%)
Cirrhosis: not stated
Very early HCC: not stated
Portal hypertension: not stated
Viral aetiology: not stated
Immunotherapy/antiviral adjuvant therapy: not stated
Average follow‐up period in months (for all groups): all participants were followed up for 12 months.
Criteria for early or very early HCC and other inclusion criteria:

  • 1 to 2 nodules, ≤ 3 cm

  • No portal vein involvement

  • No distant metastases

  • Life expectancy > 3 months
Interventions Participants were randomly assigned to 2 groups:
Group 1: radiofrequency ablation plus systemic chemotherapy (n = 15).
Further details: radiofrequency ablation with RF 2000 (RadioTherapeutics); chemotherapy with epirubicin 50 mg, cisplatin 40 mg, and floxuridine 500 mg.
Group 2: radiofrequency ablation (n = 12).
Further details: radiofrequency ablation: RF 2000 (RadioTherapeutics).
Outcomes The outcomes reported were:

  • adverse events,

  • HCC recurrence.
Notes Reasons for postrandomisation dropouts: follow‐up less than 1 year
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: this information was not available.
Allocation concealment (selection bias) Unclear risk Comment: this information was not available.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: this information was not available.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: this information was not available.
Incomplete outcome data (attrition bias)
All outcomes High risk Comment: there were postrandomisation dropouts.
Selective reporting (reporting bias) High risk Comment: important clinical outcomes expected to be measured in such trials were not reported.
For‐profit bias Unclear risk Comment: this information was not available.
Other bias Low risk Comment: no other bias noted.