Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation
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|ClinicalTrials.gov Identifier: NCT01340105|
Recruitment Status : Unknown
Verified February 2015 by Cheung Yue Sun, Chinese University of Hong Kong.
Recruitment status was: Recruiting
First Posted : April 22, 2011
Last Update Posted : February 4, 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 or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Procedure: Microwave ablation Procedure: Radiofrequency ablation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||April 2016|
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.
- Complete ablation rate [ Time Frame: 1 month ]Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340105
|Contact: Kit-fai Lee, MBBS||(852) email@example.com|
|Prince of Wales Hospital||Recruiting|
|Hong Kong, China|
|Contact: Kit-fai Lee, MBBS (852) 26321411 firstname.lastname@example.org|
|Principal Investigator: Kit-fai Lee, MBBS|
|Principal Investigator:||Kit-fai Lee, MBBS||Division of Hepato-biliary and Pancreatic Surgery, Department of Surgery, The Chinese University of Hong Kong|