Comparison of Microwave and Radiofrequency Ablation for Liver

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: microwave ablation; Device: radiofrequency ablation

• Registration Number: NCT02539212
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-31
• Last Update Submitted: 2015-08-31
• Study First Posted: 2015-09-02
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microwave ablation	microwave ablation	microwave ablation
radiofrequency ablation	radiofrequency ablation	radiofrequency ablation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
An independent Student's t-test was used for comparing treatment parameters(power, time, session,etc)between MWA and RFA.	up to 79 months
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
Wilcoxon test was used for comparing liver function between MWA and RFA.	up to 79 months

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China