A primary hepatocellular carcinoma case with tumor foci numbering less than 3, each measuring 3 cm or less, Child-Pugh score of 7 or less, ages between 20 and 79 year, and indications for either surgical resection or radiofrequency ablation for the treatment
Conditions
Interventions
Surgical resection as a primary treatment
Radiofrequency ablation as a primary treatment
Sponsors
Surgery vs. RFA (SURF) trial group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) no preceded treatment 2) tumor foci numbering less than 3 and each measuring 3 cm or less exhibiting typical findings on dynamic CT 3) no extrahepatic lesion or vascular invasion 4) Child-Pugh score of 7 or less 5) tumors which can be curatively treated with both surgery and radiofrequency ablation 6) performance status 0-2 7) bone marrow function and hepatic/renal functions are well maintained a)White blood cell count: 2000-10000/mm3 b)Platelet count of 50000/mm3 or more c)Hemoglobin of 8.0g/dL or more d)Serum total bilirubin of 2.0mg/dL or less e)Prothronbin time of 50% or more f)Serum creatinine of 1.5mg/dL or less g)Blood urea nitrogen of 35mg/dL or less
Exclusion criteria
Exclusion criteria: 1) Double cancer or history of other malignancy within 5 years after diagnosis 2) History of myocardial infarction or unstable angina within 6 months prior to registration 3) Patient with interstitial pneumonia, pneumofibrosis, or severe lung emphysema 4) Patient who cannot undergo enhanced CT scan due to some reason such as allergy for iodized contrast media or renal dysfunction 5) Patient with psychiatric disorder or symptom 6) Pregnant patient or patient with possibility to be pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival Recurrence-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function at 1, 3, and 5 years after treatment. Types of recurrence Liver function when recurrence is observed Therapeutic choice for primary recurrence Incidence of severe adverse events | — |
Countries
Japan
Contacts
Public ContactKiyoshi Hasegawa
Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division
Outcome results
None listed