Electroporation (NanoKnife) as Treatment for Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— NanoKnife  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079623
• Other study ID #: PCaNanoK
• Status: Completed
• Start date: November 2013
• Est. completion date: May 1, 2019

Study information

• Verified date: January 2020
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Electroporation/ Nano knife treatment

Device:
• NanoKnife

Locations

Country	Name	City	State
Denmark	Surgical Department of Gastroenterology, Aalborg University Hospital	Aalborg	Nothern Jutland

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	Uppsala University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain registration	Pain registration pre- and post NanoKnife treatment using the visual analogue scale of 0 to 10. Higher numbers refer to worse pain.	24 months follow up
Primary	Tumor response	According to RECIST criteria (PET-CT)	24 months follow-up
Secondary	CA-19-9	CA-19-9 measurement every 3 months	24 months follow up
Secondary	Overall survival		24 months follow-up