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The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.
By enrolling patients with renal tumors 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 renal tumors .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | irreversible electroporation with voltage in level A for renal tumors |
|
| Group B | Experimental | irreversible electroporation with voltage in level B for renal tumors |
|
| Group C | Experimental | irreversible electroporation with voltage in level C for renal tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irreversible electroporation | Procedure | Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse effects | adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al. | 1 month |
| Quality of Life (QoL) | Quality of Life assessed as WHOQOL-BREF. | 2 months |
| procedural compliance | compliance will be analyzed by 3 months of follow-up post procedure. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | efficacy assessment by percentage of lesions that show no sign of recurrence 12 months after the initial IRE procedure) of IRE for renal tumor via cross-sectional imaging and pathological examination. | 12 months |
| Voltage (A minimum and maximum range of voltage for safe and effective IRE) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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 |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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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 |
| 36 months |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |