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The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC).
The investigators hypothesize that microwave ablation can achieve a better complete ablation rate as compared to radiofrerquency ablation.
A randomized comparative study is performed by randomly assigned participants to microwave ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by the complete tumor ablation rate at 1 month, recurrence rate and survival time of participants. Safety of the procedures is also compared between the 2 treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave | Experimental | Hepatocellular carcinoma treated with microwave ablation |
|
| Radiofrequency | Active Comparator | Hepatocellular carcinoma treated with radiofrequency ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave ablation | Procedure | Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete ablation rate | Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related mortality | Mortality within 30 days after operation | 30-day |
| Recurrent disease | It is defined as the imaging detected new lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kit-fai Lee, MBBS | Department of Surgery, The Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | China |
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| 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 | Procedure | Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means. |
|
| 3 year |
| Survival | Overall and disease-free survival | 3 year |
| Long-term liver function | Monitoring of liver function test result and the occurrance of decompensated cirrhosis | 3 year |
| Treatment related morbidity | Complications related to the treatment received | 30-day |
| Hospital stay | Total length of hospital stay (days) | 30-day |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |