Electroporation (NanoKnife) as Treatment for Advanced Pancreatic Cancer

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Brief Title

Electroporation (NanoKnife) as Treatment for Advanced Pancreatic Cancer

Official Title

Implementation of Electroporation - NanoKnife as Treatment for Advanced Pancreatic Cancer.

Brief Summary

      The aim for this study is to implement electroporation therapy (NanoKnife) treatment for
      patients with locally advanced pancreatic cancer. Electroporation therapy (NanoKnife) will be
      given in addition to standard chemotherapy.
    

Detailed Description

      Pancreatic cancer has a very high mortality with a 5-year survival rate of less than 10 %.
      Even though pancreatic cancer accounts for only 2-3 % of all cancer cases, it is the 4th
      leading cause of cancer death. The best prognosis is observed in patients, where tumor is
      confined to pancreas, and where curative resection is feasible. This accounts for 5-12% of
      patients. After complete surgical resection, these patients have a median survival of 15-25
      months and a 5-year survival rate of 8-15%. Approximately 40% of patients with pancreatic
      cancer have metastatic disease at time of diagnosis, a significantly worse prognosis with a
      median survival of 6-12 months and very low long-term survival (less than 1%). The remaining
      40-50% of patients have locally advanced disease (LAPC) without metastases. It is not
      possible to do complete surgical resection of LAPC because the tumor is infiltrating the
      surrounding tissue or blood vessel. These patients also have a severe prognosis with a poor
      long-term survival and median survival time of approximately 12 months.

      The majority of patients with LAPC are offered palliative chemotherapy as standard treatment.
      Few patients are offered downstaging with chemo-radiotherapy. In rare cases downstaging
      results in extensively tumor shrink which enables subsequently surgical resection. However,
      the majority of patients remain none-resectable and only candidates for
      palliative/symptomatic treatment.

      Electroporation is a new local treatment of tumors. Tumor cells are exposed to series of
      direct current impulses with high voltage (1500 V / cm) of milliseconds duration.
      Electroporation was originally used to enhance the sensitivity of tumor cells to certain
      cytotoxic agents by increasing the permeability of the cell membrane. Later it was found that
      direct current at sufficiently high voltage can destroy the cell membrane of cancer cells
      without damaging surrounding connective tissue or blood vessels. By modulating the length of
      the impulses and voltage, this cell-killing effect is achieved without any significant
      heating of the tissue, which reduces the risk of thermal damage. Electroporation differs in
      this way from other forms of local treatment such as radiofrequency ablation (RFA), which
      acts through the heating and coagulation of tissue.

      The aim for this study is to implement electroporation therapy (NanoKnife) treatment for
      patients with locally advanced pancreatic cancer. Electroporation therapy (NanoKnife) will be
      given in addition to standard chemotherapy.
    


Study Type

Observational


Primary Outcome

Tumor response

Secondary Outcome

 CA-19-9

Condition

Pancreatic Cancer

Intervention

Electroporation/ Nano knife treatment

Study Arms / Comparison Groups

 Pancreatic cancer
Description:  Patients with locally advanced pancreatic cancer.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

33

Start Date

November 2013

Completion Date

May 1, 2019

Primary Completion Date

May 1, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Patients above 18 years old, who have given informed consent to treatment with
             electroporation

          2. Performance status <= 2 and meets one of the items below

          3. Patients diagnosed with LAPC, who are not candidate to primary curative surgical
             treatment due to tumor invasion in surrounding blood vessels or adjacent organs

          4. Patients, who have received oncological treatment with the aim of downstaging and the
             tumor still is deemed none-resectable

        Exclusion Criteria:

          1. Patients with pacemaker or similar electrostimulator (TNS, anal sphincter stimulators
             ect.)

          2. Patients for whom the anesthesia involves high risk (ASA- IV)

          3. Estimated survival of less than 3 months

          4. Metallic stent in the biliary tract, which can not be removed or changed to plastic
             stent.

          5. Performance status > 2.

          6. Pregnancy

          7. Epilepsy or other condition involving convulsions

          8. Inability to give informed consent.

          9. Patients with inability to cooperate for treatment and follow-up

         10. Severe heart disease

         11. Patients with a tumor larger than 5 cm.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ole Thorlacius-Ussing, Prof., cons., dr. med, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT02079623

Organization ID

PCaNanoK


Responsible Party

Principal Investigator

Study Sponsor

Aalborg University Hospital

Collaborators

 Uppsala University Hospital

Study Sponsor

Ole Thorlacius-Ussing, Prof., cons., dr. med, Study Chair, Department of Gastroinstestinal Surgery, Aalborg University Hospital


Verification Date

January 2020