Costanzo 2015.
Study characteristics | ||
Methods | Randomised clinical trial | |
Participants | Country: Italy Number randomised: 140 Postrandomisation dropouts: 0 (0%) Revised sample size: 140 Average age: 70 years Females: 40 (28.6%) Cirrhosis: 140 (100%) 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): not stated 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: laser (n = 70). Further details: laser: EchoLaser, Elesta s.r.l. Group 2: radiofrequency ablation (n = 70). Further details: radiofrequency ablation: Cool‐tip, Valleylab. | |
Outcomes | The outcomes reported were:
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Notes | Authors provided additional information in February 2017. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated random numbers" |
Allocation concealment (selection bias) | Unclear risk | Comment: this information was not available. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: blinding of participants and personnel was not performed (author replies). |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: blinding of outcome assessors was not performed (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 | Comment: no special source of funding (author replies) |
Other bias | Low risk | Comment: no other bias noted. |