Comparison of Microwave and Radiofrequency Ablation for Liver

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

403 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2015-06-30

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.

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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microwave ablation

Group Type ACTIVE_COMPARATOR

microwave ablation

Intervention Type DEVICE

ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients

radiofrequency ablation

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type DEVICE

ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients

Interventions

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microwave ablation

ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients

Intervention Type DEVICE

radiofrequency ablation

ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients

Intervention Type DEVICE

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes