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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:
Information provided by (Responsible Party):
Cheung Yue Sun, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01340105
First received: April 19, 2011
Last updated: February 2, 2015
Last verified: February 2015
  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
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 Cheung Yue Sun, Chinese University of Hong Kong:

Primary Outcome Measures:
  • Complete ablation rate [ Time Frame: 1 month ]
    Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)


Secondary Outcome Measures:
  • 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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

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

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

Keywords provided by Cheung Yue Sun, 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 July 21, 2017