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

Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: Microwave ablation; Procedure: Radiofrequency ablation

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microwave; Hepatocellular carcinoma treated with microwave ablation	Procedure: Microwave ablation; Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
Active Comparator: Radiofrequency; Hepatocellular carcinoma treated with radiofrequency ablation	Procedure: Radiofrequency ablation; Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete ablation rate	Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment related mortality	Mortality within 30 days after operation	30-day
Recurrent disease	It is defined as the imaging detected new lesions	3 year
Survival	Overall and disease-free survival	3 year
Long-term liver function	Monitoring of liver function test result and the occurrance of decompensated cirrhosis	3 year
Treatment related morbidity	Complications related to the treatment received	30-day
Hospital stay	Total length of hospital stay (days)	30-day

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Kit-fai Lee, MBBS, Department of Surgery, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: April 19, 2011
• First Submitted That Met QC Criteria: April 21, 2011
• First Posted (Estimate): April 22, 2011

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Radiofrequency ablation; Microwave ablation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: CT11005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No