Skip to main content
. 2017 Mar 28;2017(3):CD011650. doi: 10.1002/14651858.CD011650.pub2

Shiina 2005.

Study characteristics
Methods Randomised clinical trial
Participants Country: Japan
Number randomised: 232
Postrandomisation dropouts: 0 (0%)
Revised sample size: 232
Average age: not stated
Females: 66 (28.4%)
Cirrhosis: 198 (85.3%)
Very early HCC: not stated
Portal hypertension: not stated
Viral aetiology: 217 (93.5%)
Immunotherapy/antiviral adjuvant therapy: not stated
Average follow‐up period in months (for all groups): median: 37 months
Criteria for early or very early HCC and other inclusion criteria:

  • 1 to 3 nodules

  • No vascular invasion

  • No extrahepatic metastases

  • Child‐Pugh class A or B
Interventions Participants were randomly assigned to 2 groups:
Group 1: PEI (n = 114).
Further details: PEI using 0.5 mL to 1 mL per site (alcohol percentage not stated).
Group 2: radiofrequency ablation (n = 118).
Further details: radiofrequency ablation using CC‐1 Cosman Coagulator (Radionics).
Outcomes The outcomes reported were:

  • mortality,

  • cancer‐related mortality,

  • adverse events,

  • HCC recurrence,

  • length of hospital stay.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer‐generated random numbers"
Allocation concealment (selection bias) Unclear risk Comment: this information was not available.
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Double‐blind technique was not used because of the nature of the interventions"
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "Double‐blind technique was not used because of the nature of the interventions"
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 Unclear risk Quote: "Grants‐in‐Aid from the Ministry of Education, Science, Sports, and Culture of Japan"
Comment: not clear how the remaining part of the study was funded.
Other bias Low risk Comment: no other bias noted.

HCC: hepatocellular carcinoma; PEI: percutaneous ethanol injection; RFA: radiofrequency ablation; TACE: transarterial chemoembolisation; TAE: transarterial embolisation