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The purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress Free Survival (PFS) will be recorded.
Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis), multicentric tumors or near vital structures such as vessels, diaphragmatic dome and gallbladder. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time,Irreversible electroporation(IRE),which was applied with a novel ablation technology, can induce tissue necrosis by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoKnife IRE System | Experimental | 90 pulses of 70 microseconds each in duration will be administered per electrode pair |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoKnife | Device | Irreversible electroporation (IRE) is a new, minima-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and the gallbladder . |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging. | 30 days (+/- 3 days) post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. | Immediately post treatment to 2 years post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival(PFS) | 24months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lizhi l Niu, PHD | FUDA Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 中国 | Guangzhou | Guangdong | 510665 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |