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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| microwave ablation | Active Comparator | microwave ablation |
|
| radiofrequency ablation | Active Comparator | radiofrequency ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microwave ablation | Device | ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping Liang, Doctor | Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 5, 2016 | |
| Reset | Sep 28, 2016 | |
| Release | Feb 4, 2017 | |
| Reset | Mar 24, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 5, 2016 | Sep 28, 2016 | |||
| Feb 4, 2017 |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| radiofrequency ablation | Device | ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients |
|
| 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 |
| Mar 24, 2017 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |