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

El Kady 2013.

Study characteristics
Methods Randomised clinical trial
Participants Country: Egypt
Number randomised: 40
Postrandomisation dropouts: 0 (0%)
Revised sample size: 40
Average age: 52 years
Females: 11 (27.5%)
Cirrhosis: not stated
Very early HCC: 0 (0%)
Portal hypertension: not stated
Viral aetiology: not stated
Immunotherapy/antiviral adjuvant therapy: not stated
Average follow‐up period in months (for all groups): 6
Criteria for early or very early HCC and other inclusion criteria:

  • Single nodule > 3 cm

  • No portal vein involvement

  • No extrahepatic metastasis
Interventions Participants were randomly assigned to 2 groups:
Group 1: TACE plus radiofrequency ablation (n = 20).
Further details: TACE using 50 mg of adriamycin or cisplatin and 10 mL of ethiodised oil (Lipiodol), radiofrequency ablation with RITA 1500X RF generator and RITA StarBurst XL(RITA Medical Systems, Mountain View, CA, USA).
Group 2: radiofrequency ablation (n = 20).
Further details: radiofrequency ablation with RITA 1500X RF generator and RITA StarBurst XL(RITA Medical Systems, Mountain View, CA, USA).
Outcomes The outcomes reported were:

  • mortality,

  • adverse events,

  • HCC recurrence.
Notes Reasons for postrandomisation dropouts: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomized (computer‐based randomization) into two groups"
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 Low risk Quote: "After assigning the patients to the groups there were no drop‐outs, as the patient was assigned and managed on the same day" (author replies).
Selective reporting (reporting bias) Low risk Comment: important clinical outcomes were reported.
For‐profit bias Low risk Quote: "The conduct of the research (collection, analysis, and interpretation of data) and preparation of the article were totally funded by the authors"
Other bias Low risk Comment: no other bias noted.