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

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:
  • Single nodule < 4 cm in diameter

  • Child‐Pugh class A or B

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:
  • mortality,

  • adverse events.

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.