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The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Portal venous tumor emboli.
By enrolling patients with unresectable Portal venous tumor emboli adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for unresectable Portal venous tumor emboli.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | irreversible electroporation with voltage in level A for Unresectable Portal Venous Tumor Emboli |
|
| Group B | Experimental | irreversible electroporation with voltage in level B for Unresectable Portal Venous Tumor Emboli |
|
| Group C | Experimental | irreversible electroporation with voltage in level C for Unresectable Portal Venous Tumor Emboli |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible electroporation (IRE) | Procedure | Irreversible Electroportion For Unresectable Portal venous tumor emboli guide with ultrasound or/and CT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (adverse effects) | adverse effects | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE) | The primary objective of this project is to evaluate the efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE) | 12 months |
| Voltage (A minimum and maximum range of voltage for safe and effective IRE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lizhi Niu, PHD | Fuda Cancer Hospital | 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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|
A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice. |
| 3 months |
| Progress free disease (PFS) | Patients will be followed for 12 months after IRE for PFS assessing. | 12 months |
| Overall survival (OS) | Patients will be followed for 36 months after IRE for OS analyzed. | 36 months |
| D008107 |
| Liver Diseases |