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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Cheung Yue Sun, Chinese University of Hong Kong.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01340105
First Posted: April 22, 2011
Last Update Posted: February 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cheung Yue Sun, Chinese University of Hong Kong
April 19, 2011
April 22, 2011
February 4, 2015
April 2011
October 2015   (Final data collection date for primary outcome measure)
Complete ablation rate [ Time Frame: 1 month ]
Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)
Complete ablation rate [ Time Frame: 1 month ]
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 ]
  • Recurrent disease [ Time Frame: 3 year ]
    It is defined as the imaging detected new lesions
  • Survival [ Time Frame: 3 year ]
    Overall and disease-free survival
  • Long-term liver function [ Time Frame: 3 year ]
    Monitoring of liver function test result and the occurrance of decompensated cirrhosis
  • Treatment related morbidity [ Time Frame: 30-day ]
  • Hospital stay [ Time Frame: 30-day ]
  • Treatment related morbidity, mortality and hospital stay [ Time Frame: 30-day ]
  • Recurrent disease [ Time Frame: 3 year ]
    It is defined as the imaging detected new lesions
  • Survival [ Time Frame: 3 year ]
    Overall and disease-free survival
  • Long-term liver function [ Time Frame: 3 year ]
    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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01340105
CT11005
Not Provided
Not Provided
Not Provided
Cheung Yue Sun, 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
February 2015

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