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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Chinese University of Hong Kong
Information provided by (Responsible Party):
Cheung Yue Sun, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
First received: April 19, 2011
Last updated: February 2, 2015
Last verified: February 2015

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.

Condition Intervention Phase
Hepatocellular Carcinoma
Procedure: Microwave ablation
Procedure: Radiofrequency ablation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Complete ablation rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 92
Study Start Date: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microwave 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 Procedure: Radiofrequency ablation
Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340105

Contact: Kit-fai Lee, MBBS (852) 26321411 leekf@surgery.cuhk.edu.hk

Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Kit-fai Lee, MBBS    (852) 26321411    leekf@surgery.cuhk.edu.hk   
Principal Investigator: Kit-fai Lee, MBBS         
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Kit-fai Lee, MBBS Division of Hepato-biliary and Pancreatic Surgery, Department of Surgery, The Chinese University of Hong Kong
  More Information

Responsible Party: Cheung Yue Sun, Associate Consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01340105     History of Changes
Other Study ID Numbers: CT11005 
Study First Received: April 19, 2011
Last Updated: February 2, 2015
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Microwave ablation
Radiofrequency ablation
Randomised controlled trial

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 24, 2016