NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001795

Registered date:01/04/2009

Efficacy of surgery vs. radiofrequency ablation on primary hepatocellular carcinoma: a multicenter randomized controlled trial

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedA 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
Date of first enrollment2009/04/01
Target sample size600
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Surgical resection as a primary treatment Radiofrequency ablation as a primary treatment

Outcome(s)

Primary OutcomeOverall survival Recurrence-free survival
Secondary OutcomeLiver 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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum79years-old
GenderMale and Female
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

public contact
Name Kiyoshi Hasegawa
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan
Telephone 03-3815-5411(33321)
E-mail kihase-tky@umin.ac.jp
Affiliation Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division
scientific contact
Name Norihiro Kokudo
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan
Telephone 03-3815-5411(33321)
E-mail KOKUDO-2SU@h.u-tokyo.ac.jp
Affiliation Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division