Comparison of Microwave and Radiofrequency Ablation for Liver

Study Overview
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Brief Summary
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According to randomized controlled trial requirement, the therapeutic effectiveness of cooled-probe microwave ablation and radiofrequency ablation on early-stage hepatocellular carcinoma is compared to find a better approach for minimally invasive thermal ablation.

Detailed Description
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According to following enrollment standard, about >400 cases of biopsy-proved hepatocellular carcinoma(HCC) patients will be involved in the study. They will be treated with percutaneously microwave ablation (MWA) and radiofrequency ablation(RFA). The indications of patients enrolled in the study were as follows: tumor size ≤5cm in diameter, tumor number ≤3, Child-Pugh class A or B classification, no evidence of extrahepatic metastasis, vein or bile duct tumor embolus, and no any other anti-cancer treatment was accepted. MWA or RFA is selected for the patient according to the sequence of their visit to the hospital based on randomization number arrangement produced by SPSS 16.0 statistical software. The therapeutic effectiveness will be compared between two modalities.

Official Title
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A Randomized Controlled Trial of Microwave and Radiofrequency Ablation in the Treatment of Early-stage Hepatocellular Carcinoma Meeting Milan Criteria

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: microwave ablation
* Device: radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: tumor size ≤5cm in diameter, tumor number ≤3, Child-Pugh class A or B classification, no evidence of extrahepatic metastasis, vein or bile duct tumor embolus, and no any other anti-cancer treatment Exclusion Criteria: not meeting the inclusion criteria

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: microwave ablation<br>microwave ablation | Device: microwave ablation<br>* ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients<br>|
| Active Comparator: radiofrequency ablation<br>radiofrequency ablation | Device: radiofrequency ablation<br>* ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test. |  | up to 79 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test. |  | up to 79 months | 
| Local tumor progress rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test. |  | up to 79 months | 
| An independent Student's t-test was used for comparing treatment parameters(power, time, session,etc)between MWA and RFA. |  | up to 79 months | 
| Wilcoxon test was used for comparing liver function between MWA and RFA. |  | up to 79 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microwave, radiofrequency, ablation