Lencioni 2003.
Study characteristics | ||
Methods | Randomised clinical trial | |
Participants | Country: Italy
Number randomised: 104
Postrandomisation dropouts: 2 (1.9%)
Revised sample size: 102
Average age: 68 years
Females: 36 (35.3%)
Cirrhosis: 102 (100%)
Very early HCC: not stated
Portal hypertension: not stated
Viral aetiology: 82 (80.4%)
Immunotherapy/antiviral adjuvant therapy: not stated
Average follow‐up period in months (for all groups): mean: 23 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 = 50). Further details: PEI using 2 to 10 mL 95% alcohol per session. Group 2: radiofrequency ablation (n = 52). Further details: radiofrequency ablation using 500L RITA Medical Systems. | |
Outcomes | The outcomes reported were:
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Notes | Reasons for postrandomisation dropouts:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated randomization list" |
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) | Low risk | Comment: important clinical outcomes were reported. |
For‐profit bias | Unclear risk | Comment: this information was not available. |
Other bias | Low risk | Comment: no other bias noted. |