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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Chinese University of Hong Kong
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01340105
First received: April 19, 2011
Last updated: January 17, 2012
Last verified: January 2012

April 19, 2011
January 17, 2012
April 2011
October 2015   (final data collection date for primary outcome measure)
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)
Complete ablation rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Measure by post-ablation CT with reference to AFP
Complete list of historical versions of study NCT01340105 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
92
April 2016
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kit-fai Lee, MBBS (852) 26321411 leekf@surgery.cuhk.edu.hk
China
 
NCT01340105
CT11005
Not Provided
Dr Kit-fai Lee, Division of Hepato-biliary and Pancreatic Surgery, Department of Surgery, The Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Kit-fai Lee, MBBS Division of Hepato-biliary and Pancreatic Surgery, Department of Surgery, The Chinese University of Hong Kong
Chinese University of Hong Kong
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP