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Trial record 31 of 130 for:    Pancreatic Cancer | ( Map: South Korea )

Safety and Efficacy of Irreversible Electroporation for Locally Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02898649
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Cancer Device: Irreversible electroporation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IRE
The intervention group
Device: 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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: from 1 month to 3 month ]
    Overall survival is calculated from the date of informed consent acquisition until the date of death.

  2. Safety (frequency of procedure-related complication and death) [ Time Frame: from 1 month to 3 month ]
    Safety is evaluated by the frequency of procedure-related complication and death.


Secondary Outcome Measures :
  1. Time to progression [ Time Frame: within 1 year ]
  2. Tumor control [ Time Frame: within 1 year ]
  3. Pain control [ Time Frame: within 1 year ]
  4. Change in CA 19-9 [ Time Frame: within 1 year ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898649


Contacts
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Contact: Seung Min Bang, MD +82 2 2228 1995 BANG7028@yuhs.ac

Locations
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Korea, Republic of
Yonsei university of medical center Recruiting
Seoul, Korea, Republic of, 03722
Contact: Seung Min Bang, MD    +82 2 2228 1995    BANG7028@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02898649     History of Changes
Other Study ID Numbers: 4-2015-0150
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases