Safety and Efficacy of Irreversible Electroporation for Locally Advanced Pancreatic Cancer

Not Applicable

• Conditions: Locally Advanced Pancreatic Cancer
• Interventions: Device: Irreversible electroporation

• Registration Number: NCT02898649
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-13
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Pathologically confirmed pancreatic cancer patients
• Locally advanced pancreatic cancer patients. Vascular encasement by tumor was noted in radiological evaluation (CT, MRI or PET-CT)
• Older than 19 years old and younger than 70 years old
• Previously treated with systemic chemotherapy or chemoradiotherapy due to locally advanced pancreatic cancer.

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Exclusion Criteria

• Patients with life-threatening systemic disease.
• Metastatic or borderline-resectable pancreatic cancer patients
• Patients with seizure history
• Patients with arrythmia or heart failure
• Recent history of myocardial infarction (within 1 year)
• Patients who have implantable electronic devices. (e.g. pacemaker, defibrillator)
• Patients who have metal devices (e.g. metal stent) around tumor.
• Coagulopathy patients.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IRE	Irreversible electroporation	The intervention group

Primary Outcome Measures

Name	Time	Method
Safety (frequency of procedure-related complication and death)	from 1 month to 3 month	Safety is evaluated by the frequency of procedure-related complication and death.
Overall survival	from 1 month to 3 month	Overall survival is calculated from the date of informed consent acquisition until the date of death.

Secondary Outcome Measures

Name	Time	Method
Tumor control	within 1 year
Time to progression	within 1 year
Change in CA 19-9	within 1 year
Pain control	within 1 year

Trial Locations

Locations (1)

Yonsei university of medical center; 🇰🇷 Seoul, Korea, Republic of