The purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress Free Survival (PFS) and Over Survival (OS) 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) which directly lead a poor liver function. 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 necross 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
90 pulses of 70 microseconds each in duration will be administered per electrode pair
FUDA Cancer Hospital
Guangzhou, Guangdong, China
Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.
Time frame: 1 day post treatment to 14 days post treatment
Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
Time frame: 30 days (+/- 3 days) post treatment
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