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

UMIN ID: UMIN000001795

Registered date:01/04/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: 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
• Date of first enrollment: 2009/04/01
• Target sample size: 600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Surgical resection as a primary treatment
Radiofrequency ablation as a primary treatment

Outcome(s)

• Primary Outcome: Overall survival Recurrence-free survival
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Surgery vs. RFA (SURF) trial group
• Secondary Sponsor: None
• Source(s) of Monetary Support: A grant-in-aid for Scientific Research from the Ministry of Health, Labour and Welfare,Japanese Foundation for Multidisciplinary Treatment of Cancer