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

Huang 2010.

Study characteristics
Methods Randomised clinical trial
Participants Country: China
Number randomised: 230
Postrandomisation dropouts: 0 (0%)
Revised sample size: 230
Average age: 56 years
Females: 66 (28.7%)
Cirrhosis: 142 (61.7%)
Very early HCC: not stated
Portal hypertension: not stated
Viral aetiology: 215 (93.5%)
Immunotherapy/antiviral adjuvant therapy: not stated
Average follow‐up period in months (for all groups): median: 42 months
Criteria for early or very early HCC and other inclusion criteria:

  • Milan criteria

  • Child A or B

  • No vascular invasion

  • No distant metastases
Interventions Participants were randomly assigned to 2 groups:
Group 1: surgery (n = 115).
Further details: not stated whether open or laparoscopic resection.
Group 2: radiofrequency ablation (n = 115).
Further details: radiofrequency ablation using Cool‐tip (Radionics).
Outcomes The outcomes reported were:

  • mortality,

  • cancer‐related mortality,

  • adverse events,

  • HCC recurrence,

  • length of hospital stay.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomization method with a computer"
Allocation concealment (selection bias) Low risk Quote: "Physicians received the envelope for each patient in the registry sequence kept in a container given by the statistician and kept by the chief nurse of our center."
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Because of the nature of the interventions, the double‐blind technique was not used"
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "Because of the nature of the interventions, the double‐blind technique was not used"
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: there were no postrandomisation dropouts.
Selective reporting (reporting bias) Low risk Comment: important clinical outcomes were reported.
For‐profit bias Low risk Quote: "This study has not received any support from industry or private corporations."
Other bias Low risk Comment: no other bias noted.