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:
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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:
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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. |
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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. |