Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome
NCT ID: NCT02329106
Last Updated: 2021-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2014-12-01
2021-01-01
Brief Summary
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Detailed Description
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This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to close to diaphragmatic dome, where the current therapeutic arsenal is inadequate or counter-indicated.
To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NanoKnife LEDC System
Ablation with the NanoKnife Low Energy Direct Current (LEDC) System, alao called Irreversible electroporation (IRE), 90 pulses of 70 microseconds each in duration will be administered per electrode pair.
Irreversible electroporation (IRE)
Irreversible electroporation (IRE) is a new, minimal-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 diaphragmatic dome.
Control
The patients without treatment
No interventions assigned to this group
Interventions
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Irreversible electroporation (IRE)
Irreversible electroporation (IRE) is a new, minimal-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 diaphragmatic dome.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumors from diaphragm is \<1 cm
* not suitable for surgical resection or transplantation,
* have at least one, but less than or equal to 3 tumors,
* of the tumour(s) identified, each tumor must be ≤ 5 cm in diameter,
* Child-Pugh class A,B
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* a prothrombin time ratio \> 50%,
* platelet count \> 80x109/L,
* ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* are able to comprehend and willing to sign the written informed consent form (ICF),
* have a life expectancy of at least 3 months.
Exclusion Criteria
* cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* any active implanted device (eg Pacemaker),
* women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
18 Years
75 Years
ALL
No
Sponsors
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Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
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Principal Investigators
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Lizhi Niu, M.D.,PHD.
Role: STUDY_CHAIR
President
Locations
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FUDA Cancer Hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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JF-20141225
Identifier Type: -
Identifier Source: org_study_id
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