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The purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome.
Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of liver cancer close to diaphragmatic dome.
This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to close to diaphragmatic dome, where the current therapeutic arsenal is inadequate or counter-indicated.
To perform the IRE procedure the IRE NanoKnifeâ„¢ System (AngioDynamics) will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoKnife LEDC System | Experimental | Ablation with the NanoKnife Low Energy Direct Current (LEDC) System, alao called Irreversible electroporation (IRE), 90 pulses of 70 microseconds each in duration will be administered per electrode pair. |
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| Control | No Intervention | The patients without treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible electroporation (IRE) | Device | Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and diaphragmatic dome. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of IRE for unresectable liver cancer close to diaphragmatic dome using Common terminology Criteria for Adverse Events (CTCAE). | Safety using Common terminology Criteria for Adverse Events (CTCAE). | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of IRE for unresectable liver cancer close to diaphragmatic as measured by cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC) | Cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC). Since and shape of the ablation zone is assessed. Immunohistologic examination is used to more specifically assess microscopic cell damage and vessel wall damage. Apoptotic markers are used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lizhi Niu, M.D.,PHD. | President | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FUDA Cancer Hospital | Guangzhou | Guangdong | 510665 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
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|
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| 1 year |
| D008107 |
| Liver Diseases |