Safety and Efficacy of Irreversible Electroporation for Locally Advanced Pancreatic Cancer

NCT ID: NCT02898649

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-08-31

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.

Conditions

Locally Advanced Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IRE

The intervention group

Group Type: EXPERIMENTAL

Irreversible electroporation

Intervention Type: DEVICE

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.

Interventions

Irreversible electroporation

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei university of medical center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Seung Min Bang, MD

Role: CONTACT

BANG7028@yuhs.ac

+82 2 2228 1995

Facility Contacts

Seung Min Bang, MD

Role: primary

BANG7028@yuhs.ac

+82 2 2228 1995

Other Identifiers

4-2015-0150

Identifier Type: -

Identifier Source: org_study_id