Hepatocellular Carcinoma
Conditions
Keywords
microwave, radiofrequency, ablation
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.
Interventions
DEVICEmicrowave ablation
ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients
DEVICEradiofrequency ablation
ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
China
Outcome results
None listed