Orlacchio 2014.
Study characteristics | ||
Methods | Randomised clinical trial | |
Participants | Country: Italy Number randomised: 30 Postrandomisation dropouts: 0 (0%) Revised sample size: 30 Average age: 72 years Females: 9 (30%) Cirrhosis: 30 (100%) Very early HCC: not stated Portal hypertension: 30 (100%) Viral aetiology: 27 (90%) Immunotherapy/antiviral adjuvant therapy: not stated Average follow‐up period in months (for all groups): all participants were followed up for 12 months. Criteria for early or very early HCC and other inclusion criteria:
|
|
Interventions | Participants were randomly assigned to 2 groups: Group 1: laser (n = 15). Further details: laser using EchoLaser XVG system. Group 2: radiofrequency ablation (n = 15). Further details: radiofrequency ablation using RF 3000, Boston Scientific Corporation. | |
Outcomes | The outcomes reported were:
|
|
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: "randomisation software was used to allocate each patient to a treatment group" |
Allocation concealment (selection bias) | Unclear risk | Quote: "randomisation software was used to allocate each patient to a treatment group" Comment: further details were not available. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: participants and personnel were not blinded (based on author replies). |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: outcome assessors were not blinded (based on 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. |