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

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:
  • Milan criteria

  • Child A or B

  • No vascular invasion

  • No distant metastases

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:
  • mortality,

  • cancer‐related mortality,

  • adverse events,

  • HCC recurrence.

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.