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:
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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. |