Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation

• Treatment related mortality [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
• Recurrent disease [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  It is defined as the imaging detected new lesions
• Survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  Overall and disease-free survival
• Long-term liver function [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
  Monitoring of liver function test result and the occurrance of decompensated cirrhosis
• Treatment related morbidity [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
• Hospital stay [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]

• Treatment related morbidity, mortality and hospital stay [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
• Recurrent disease [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  It is defined as the imaging detected new lesions
• Survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  Overall and disease-free survival
• Long-term liver function [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
  Monitoring of liver function test result and the occurrance of decompensated cirrhosis

The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC).

The investigators hypothesize that microwave ablation can achieve a better complete ablation rate as compared to radiofrerquency ablation.

A randomized comparative study is performed by randomly assigned participants to microwave ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by the complete tumor ablation rate at 1 month, recurrence rate and survival time of participants. Safety of the procedures is also compared between the 2 treatment arms.

• Procedure: Microwave ablation
  Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
• Procedure: Radiofrequency ablation
  Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.

• Experimental: Microwave
  Intervention: Procedure: Microwave ablation
• Active Comparator: Radiofrequency
  Intervention: Procedure: Radiofrequency ablation

Inclusion Criteria:

• Age >18 years
• Unresectable hepatocellular carcinoma (HCC) and tumor amendable for local ablation
• Resectable HCC but patient opts for local ablation
• Maximum diameter of tumor ≤6cm
• Maximum number of tumor nodules ≤3
• Absence of radiology evidence of major vascular or bile duct invasion
• Child's A or B liver function
• Karnofsky performance status ≥70%

Exclusion Criteria:

• Informed consent not available
• Pregnant female patients
• Tumors unfavourable for local ablation (e.g. tumor close to porta hepatis)
• HCC with history of rupture
• Concomitant hepatectomy
• Patients with chronic renal failure