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

Giorgio 2011.

Study characteristics
Methods Randomised clinical trial
Participants Country: Italy
Number randomised: 285
Postrandomisation dropouts: 0 (0%)
Revised sample size: 285
Average age: 70 years
Females: 78 (27.4%)
Cirrhosis: 285 (100%)
Very early HCC: 71 (24.9%)
Portal hypertension: not stated
Viral aetiology: 285 (100%)
Immunotherapy/antiviral adjuvant therapy: not stated
Average follow‐up period in months (for all groups): mean: 37 months
Criteria for early or very early HCC and other inclusion criteria:
  • Single nodule, ≤ 3 cm

Interventions Participants were randomly assigned to 2 groups:
Group 1: PEI (n = 143).
Further details: PEI using 4 to 20 mL of 95% ethanol depending upon tumour volume.
Group 2: radiofrequency ablation (n = 142).
Further details: radiofrequency ablation generator details not stated.
Outcomes The outcomes reported were:
  • mortality,

  • adverse events.

Notes Although mortality was reported, this was a severely biased estimate, as 14 people who could not undergo radiofrequency ablation were excluded. We therefore did not use the survival information.
Authors provided additional information in February 2017.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "random number generator"
Allocation concealment (selection bias) Low risk Quote: "The person randomising the patient were unaware of what the next treatment allocation was. It was used a centralised randomisation service to ensuring allocation concealment. So it was not possible for the investigators to know the allocation sequence in advance" (author replies)
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "The patients and healthcare providers were not blinded due to the nature of the treatments used in to the study (PEI versus RFA)" (author replies)
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "The outcome assessors were blinded as they did not know the patient was referring to the results" (author replies)
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: "The study was not funded. It was self‐financed by the hospital" (author replies)
Other bias Low risk Comment: no other bias noted.