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Trial record 1 of 1 for:    NCT01340105
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Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation

This study is currently recruiting participants.
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
History of Changes
  Purpose

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

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.

  Eligibility

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

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

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

Locations
China
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
Investigators
Principal Investigator: Kit-fai Lee, MBBS Division of Hepato-biliary and Pancreatic Surgery, Department of Surgery, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr Kit-fai Lee, Division of Hepato-biliary and Pancreatic Surgery, Department of Surgery, The 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: January 17, 2012
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
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 19, 2013