Irreversible Electroporation(IRE) For Unresectable Gallbladder Neoplasms
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Gallbladder Neoplasms.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: IRE Group irreversible electroporation for Unresectable Gallbladder Neoplasms |
Procedure: Irreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.
Other Names:
Device: NanoKnife
|
No Intervention: Control The patients without treatment |
Outcome Measures
Primary Outcome Measures
- Number of participants with Adverse events [6 month]
Secondary Outcome Measures
- 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]
- Progress free disease (PFS) [12 months]
- Overall survival (OS) [36 months]
Patients will be followed for 36 months after IRE for OS analyzed.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Gallbladder Neoplasms diagnosed by positive biopsy or non-invasive criteria,
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Not suitable for surgical resection,
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Eastern Cooperative Oncology Group (ECOG) score of 0-1,
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A prothrombin time ratio > 50%,
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Platelet count > 80x10^9/L,
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Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
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Able to comprehend and willing to sign the written informed consent form (ICF),
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Have a life expectancy of at least 3 months.
Exclusion Criteria:
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Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
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Any active implanted device (eg Pacemaker),
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Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
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Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnifeā¢ LEDC System,
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Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Biological treatment center in Fuda cancer hospital | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Fuda Cancer Hospital, Guangzhou
Investigators
- Study Chair: Lizhi Niu, PhD, Fuda Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Gallbladder Neoplasms-IRE-01