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

Brunello 2008.

Study characteristics
Methods Randomised clinical trial
Participants Country: Italy
Number randomised: 139
Postrandomisation dropouts: 0 (0%)
Revised sample size: 139
Average age: 70 years
Females: 47 (33.8%)
Cirrhosis: 139 (100%)
Very early HCC: not stated
Portal hypertension: not stated
Viral aetiology: 114 (82%)
Immunotherapy/antiviral adjuvant therapy: not stated
Average follow‐up period in months (for all groups): all participants: 36 months
Criteria for early or very early HCC and other inclusion criteria:

  • 1 to 3 nodules, < 3 cm diameter

  • Child‐Pugh class A or B


Exclusion criteria:

  • Hypovascular HCC

  • Lesions not detectable by ultrasound

  • Lesions close to the gallbladder, hilum of liver, colon, or stomach

  • Venous invasion

  • Metastatic disease

  • Liver transplantation
Interventions Participants were randomly assigned to 2 groups:
Group 1: PEI (n = 69).
Further details: 2 to 20 mL ethanol (95%).
Group 2: radiofrequency ablation (n = 70).
Further details: Cool‐tip or StarBurst system for radiofrequency ablation.
Outcomes The outcomes reported were:

  • 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: "computerized random generator"
Allocation concealment (selection bias) Low risk Quote: "closed, sequentially numbered envelopes"
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "the healthcare providers were blinded until the opening of the sealed envelopes containing the assignation from the randomized list. The same for the patients, who were informed about their treatment (PEI or RF) after the opening of the envelope and were thereafter scheduled for the appropriate treatment" (author replies)
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: after treatment, evaluations of computed tomography by a ‘‘blinded’’ observer were considered not feasible because of different radiological signs produced by the 2 techniques.
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 Quote: "The work of Eva Pagano was supported by the Compagnia di San Paolo."
Other bias Low risk Comment: no other bias noted.