A randomized controlled trial for the comparison of radiofrequency ablation with and without transcatheter arterial chemoembolization for patients with hepatocellular carcinoma

UMIN ID: UMIN000002083

Registered date:18/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: hepatocellular carcinoma
• Date of first enrollment: 2005/09/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

TACE-RFA group: Transcatheter arterial chemoembolization (TACE) was performed by selectively introducing a microcatheter into the right/left hepatic artery or tumor feeding arteries injecting epirubicin, lipiodol, and gelatin sponge. Within 24 hours after TACE, radiofrequency ablation (RFA) was performed percutaneously using multitined expandable electrodes or internally cooled electrodes.
RFA group: RFA was performed percutaneously using multitined expandable electrodes or internally cooled electrodes.

Outcome(s)

• Primary Outcome: Time to recurrence (TTR)
• Secondary Outcome: Overall survival (OS) Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) History of any other cancer curatively treated < 3years prior to study entry 2) Uncontrolled ascites or pleural effusion 3) Active clinically serious infection ( > grade 2 NCI) 4) Uncontrolled diabetes mellitus or ileus 5) Having with extrahepatic spread HCC tumors 6) Pregnant or breast-feeding patients 7)Known or suspected allergy to iodine or any agents given in this trial 8) Active coronary artery disease less than 3 months prior to study entry 9) Psychological conditions that may interfere with the patient's compliance and evaluation of the study results 10) Evidence of tumor thrombosis in hepatic veins, portal veins, and/or bile ducts 11) Evidence of arterio-portal shunting in liver Any condition that is unstable or which could jeopardize the safety of the subject and their compliance in this study

Related Information

• Primary Sponsor: Yokohama City University Medical Center Gastroenterological Center
• Source(s) of Monetary Support: Yokohama Foundation for Advancement of Medical Science