Neoplasms Clinical Trial
Official title:
Clinical Trials of CT-guided Percutaneous Irreversible Electroporation(IRE)in the Treatment of Patients With Locally Advanced Tumors:The Safety and Efficacy Assessment
Irreversible electroporation (IRE) is an emerging nonthermal focal ablation technique that uses a series of short but intense electric pulses delivered by NanoKnife generator through paired electrodes into a targeted region of tissue, inducing the cells death by apoptosis through irreversibly disrupting cellular membrane integrity. This study aimed to investigate the safety and efficacy of CT-guided percutaneous irreversible electroporation(IRE) in the treatment of patients with locally advanced tumors in different anatomical position.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Histologically confirmed locally advanced solid tumor. 2. Unresectable tumors or the patient refused surgical therapy. 3. Patients in good health conditions can receive general anesthesia. 4. Patients with good compliance can cooperate with doctors for related tests and the regular follow-up. Exclusion Criteria: 1. Targeted tissues that metallic wallstents or metallics were implanted. 2. With heart pacemaker or be allergic to contrast medium that can not have related imaging examinations. 3. With bleeding and psychiatric disorders. 4. Severe arrhythmia. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The Chinese PLA General Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Yueyong Xiao |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | effective rate of IRE ablation | The procedure-related result will be assess by the size,blood supply,metabolism of the tumors. The changes of blood test are also considerable. | up to 12 months after the procedures | No |
Secondary | 1-year survival rates | up to 12 months after the procedures | No | |
Secondary | complication rate | the frequency of adverse events,including early and late complications | During the procedure or up to 12 months after the ablation procedure | Yes |
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