Clinical trial NCT02898649: Safety and Efficacy of Irreversible Electroporation for Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Locally Advanced Pancreatic Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall survival
timeFrame: from 1 month to 3 month
measure: Safety (frequency of procedure-related complication and death)
timeFrame: from 1 month to 3 month
Secondary outcomes:
measure: Time to progression
timeFrame: within 1 year
measure: Tumor control
timeFrame: within 1 year
measure: Pain control
timeFrame: within 1 year
measure: Change in CA 19-9
timeFrame: within 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university of medical center
Study officials:
References: