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The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for Lung Neoplasms accompanied by Respiratory Function Insufficiency.
By enrolling patients with Lung Neoplasms accompanied by Respiratory Function Insufficiency adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for Lung Neoplasms accompanied by Respiratory Function Insufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRE Group | Experimental | irreversible electroporation for Lung Neoplasms accompanied by Respiratory Function Insufficiency |
|
| Control | No Intervention | The patients without treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible electroporation (IRE) | Procedure | Irreversible Electroportion For Lung Neoplasms accompanied by Respiratory Function Insufficiency guide with ultrasound or/and CT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse events | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of lesions that show no sign of recurrence 12 months after IRE | 12 months | |
| A minimum and maximum range of voltage for safe and effective IRE | A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice. |
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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 |
|---|---|---|---|---|---|---|
| Biological treatment center in Fuda cancer hospital | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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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|
| NanoKnife | Device |
|
| 3 months |
| Progress free disease (PFS) | A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice. | 12 months |
| Overall survival (OS) | Patients will be followed for 36 months after IRE for OS analyzed. | 36 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |