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The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Gallbladder Neoplasms.
By enrolling patients with unresectable Gallbladder Neoplasms 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 Gallbladder Neoplasms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRE Group | Experimental | irreversible electroporation for Unresectable Gallbladder Neoplasms |
|
| Control | No Intervention | The patients without treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible electroporation (IRE) | Procedure | Irreversible Electroportion For Unresectable Rectal 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 | 3 months | |
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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 |
|---|---|
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System 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 |
|
| Progress free disease (PFS) |
| 12 months |
| Overall survival (OS) | Patients will be followed for 36 months after IRE for OS analyzed. | 36 months |
| D001660 |
| Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |