Pancreatic cancer is 5th leading cause of cancer-related death in Korea. It has a dismal prognosis with very low 5-year survival rate, about 5%. Only 10% of pancreatic cancer patients is diagnosed in operable status. So, most of patients could not be treated with curative resection. Locally advanced pancreatic cancer (LAPC) is defined by defined as surgically unresectable due to vascular encasement (e.g. celiac trunk or superior mesenteric artery) by tumor, but have no evidence of distant metastases. In LAPC patients, systemic chemotherapy with/without radiotherapy was used as a standard therapy, but therapeutic response was very poor. Only less than 30% of patients showed treatment response, and median survival of LAPC patient was only 9 months. Thus, more effective treatment modality is needed for LAPC patients. Irreversible electroporation (IRE) is a soft tissue ablation technique using ultra short but strong electrical fields to create permanent and hence lethal nanopores in the cell membrane, to disrupt the cellular homeostasis. IRE does not cause thermally induced necrosis and has tissue selectivity, so adjacent tissue or vascular structures can be preserved. Several clinical trials using IRE were performed to liver, kidney or lung cancer patients. We will operate IRE procedure to LAPC patients who were previously received standard therapy but showed no response, using NanoKnife IRE device. We will investigate treatment response and safety of IRE.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
IRE is operated to tumor under laparotomy or CT-guided percutaneous approach. Unipolar (19G) or bipolar (16G) electrode probe is inserted to around tumor. After insertion of probe, short duration (70-90㎲) of electric current (25\~45A) is generated by IRE device (NanoKnife IRE device, AngioDynamics, Queens bury, New York). It is possible to obtain a three-dimensional ablation zone using multiple electrode. IRE can cause apoptosis of tumor cells, without adjacent tissue damage.
Yonsei university of medical center
Seoul, South Korea
RECRUITINGOverall survival
Overall survival is calculated from the date of informed consent acquisition until the date of death.
Time frame: from 1 month to 3 month
Safety (frequency of procedure-related complication and death)
Safety is evaluated by the frequency of procedure-related complication and death.
Time frame: from 1 month to 3 month
Time to progression
Time frame: within 1 year
Tumor control
Time frame: within 1 year
Pain control
Time frame: within 1 year
Change in CA 19-9
Time frame: within 1 year
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