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

Koda 2001.

Study characteristics
Methods Randomised clinical trial
Participants Country: Japan
Number randomised: 52
Postrandomisation dropouts: not stated
Revised sample size: 52
Average age: 66 years
Females: 22 (42.3%)
Cirrhosis: 46 (88.5%)
Very early HCC: not stated
Portal hypertension: not stated
Viral aetiology: 49 (94.2%)
Immunotherapy/antiviral adjuvant therapy: not stated
Average follow‐up period in months (for all groups): mean: 30
Criteria for early or very early HCC and other inclusion criteria:
  • 1 to 3 nodules, ≤ 3 cm

  • No portal thrombosis

  • No extrahepatic metastases

Interventions Participants were randomly assigned to 2 groups:
Group 1: TACE plus PEI (n = 26).
Further details: TACE using iodised oil, epirubicin hydrocholoride, and gelatin sponge; PEI using 1 to 12 mL absolute alcohol per session.
Group 2: PEI (n = 26).
Further details: PEI using 1 to 12 mL absolute alcohol per session.
Outcomes The outcomes reported were:
  • mortality,

  • cancer‐related mortality,

  • adverse events.

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 Quote: "sealed‐envelope method"
Comment: further details were 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) 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.