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

Bolondi 1996.

Study characteristics
Methods Randomised clinical trial
Participants Country: Italy
Number randomised: 150
Postrandomisation dropouts: not stated
Revised sample size: 150
Average age: not stated
Females: not stated
Cirrhosis: 150 (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): mean: 19 months
Criteria for early or very early HCC and other inclusion criteria:
  • < 5 cm unifocal lesions

Interventions Participants were randomly assigned to 2 groups:
Group 1: PEI plus TACE (n = 66).
Further details not available for TACE or PEI.
Group 2: PEI (n = 84).
Further details not available.
Outcomes The outcomes reported were: mortality.
Notes Reasons for postrandomisation dropouts: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: this information was not available.
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 Unclear risk Comment: this information was not available.
Selective reporting (reporting bias) High risk Comment: important clinical outcomes expected to be measured in such trials were not reported.
For‐profit bias Unclear risk Comment: this information was not available.
Other bias Low risk Comment: no other bias noted.