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

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:
  • Milan criteria

  • Child class A or B

  • No vascular invasion

  • No distant metastases

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:
  • mortality,

  • cancer‐related mortality,

  • adverse events.

Notes Reasons for postrandomisation dropouts:
  1. Tumour size > 5 cm.

  2. Extrahepatic cancer identified retrospectively.

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.