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

March 5, 2022 updated by: Cheung Yue Sun, Chinese University of Hong Kong

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 month
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
Time Frame: 30-day
Mortality within 30 days after operation
30-day
Recurrent disease
Time Frame: 3 year
It is defined as the imaging detected new lesions
3 year
Survival
Time Frame: 3 year
Overall and disease-free survival
3 year
Long-term liver function
Time Frame: 3 year
Monitoring of liver function test result and the occurrance of decompensated cirrhosis
3 year
Treatment related morbidity
Time Frame: 30-day
Complications related to the treatment received
30-day
Hospital stay
Time Frame: 30-day
Total length of hospital stay (days)
30-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT11005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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