Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for Hilus Pumonis Neoplasms.
By enrolling patients with unresectable Head and Hilus Pulmonis 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 unresectable Hilus Pulmonis Neoplasms.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRE Group | Experimental | irreversible electroporation for Unresectable Hilus Pulmonis Neoplasms |
|
| Control | No Intervention | The patients without treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible electroporation (IRE) | Procedure | Irreversible Electroportion For Unresectable Hilus Pulmonis Neoplasms 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| ID | Term |
|---|---|
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NanoKnife | Device |
|
| 3 months |
| Progress free disease (PFS) | 12 months |
| Overall survival (OS) | Patients will be followed for 36 months after IRE for OS analyzed. | 36 months |