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

Study Overview
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Brief Summary
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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.

Official Title
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Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Microwave ablation
* Procedure: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microwave<br>Hepatocellular carcinoma treated with microwave ablation | Procedure: Microwave ablation<br>* Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.<br>|
| Active Comparator: Radiofrequency<br>Hepatocellular carcinoma treated with radiofrequency ablation | Procedure: Radiofrequency ablation<br>* Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete ablation rate | Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related mortality | Mortality within 30 days after operation | 30-day | 
| Recurrent disease | It is defined as the imaging detected new lesions | 3 year | 
| Survival | Overall and disease-free survival | 3 year | 
| Long-term liver function | Monitoring of liver function test result and the occurrance of decompensated cirrhosis | 3 year | 
| Treatment related morbidity | Complications related to the treatment received | 30-day | 
| Hospital stay | Total length of hospital stay (days) | 30-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microwave ablation, Radiofrequency ablation, Randomised controlled trial