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:
|
|
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:
|
|
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. |