Ablation of Unresectable Locally Advanced Pancreatic Cancer With Irreversible Electroporation (IRE) System

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Brief Title

Ablation of Unresectable Locally Advanced Pancreatic Cancer With Irreversible Electroporation (IRE) System

Official Title

Ablation of Unresectable Locally Advanced Pancreatic Cancer With Nanoknife Irreversible Electroporation (IRE) System: Response and Tolerability

Brief Summary

      Patients with pancreatic ductal adenocarcinoma will be screened by pancreatic protocol
      cross-sectional imaging to see if they have locally advanced unresectable pancreatic ductal
      adenocarcinoma. Patients with unresectable disease will undergo at least four cycles of
      standard of care chemotherapy before being re-evaluated for treatment with irreversibe
      electroporation (i.e., Nanoknife). If patients are over 18 years of age, have pancreatic
      tumor size less than 5cm, and can safely undergo a laparotomy, they will be considered for
      participation. The patient cannot undergo the procedure if they have metastatic disease, a
      pacemaker or an electrostimulator, a metallic stent that cannot be exchanged, a convulsive
      (i.e., epilepsy) condition, an estimated survival less than three months, atrial fibrillation
      with an undetectable waveform on ECG sync device, severe cardiac disease, a international
      normalised ratio (INR) that is less than 1.5, or a performance status >2.

      For the procedure, a laparotomy will be performed and Nanoknife probe placement will be done
      under intraoperative ultrasound. The number of probes, depth of the probes and rapid pulse
      series will be decided by the surgeon and are based on the size and location of the desired
      area of ablation.

      Patients will be followed for overall survival, progression-free survival, tumor response,
      tumor markers, symptom improvement, and complications. Symptom improvement will be measured
      by assessment of pain, quality of life, total bilirubin if biliary obstruction is initially
      present, and oral intake if gastric outlet obstruction is initially present. They will have
      regular follow up with the surgeon that will include routine surveillance imaging and blood
      work.
    

Detailed Description

      Pancreatic ductal adenocarcinoma is extremely aggressive and is the 4th most frequent
      tumor-related cause of death in the Western world. The one-year survival rate is 20 percent
      and the 5-year overall survival rate is only 5 percent. Pancreatic ductal adenocarcinoma
      often become symptomatic at very advanced stages with only 15 to 20 percent of patients being
      able to undergo a therapeutic local resection. Patients who do not meet the criteria for
      local consolidative resection may either have advanced locoregional disease and/or distant
      metastases. Advanced locoregional pancreatic ductal adenocarcinoma without metastatic disease
      has a survival rate of 6 to 12 months. Those with distant metastases have a survival rate of
      only 3 to 6 months.

      Locally advanced pancreatic adenocarcinoma is defined by the involvement of the superior
      mesenteric artery, the celiac axis, and/or long segment portal vein occlusion on
      cross-sectional imaging. Resectable tumors will be free from the superior mesenteric vein,
      superior mesenteric artery and celiac axis, with no nodal involvement outside of the area of
      resection. Unresectable disease will have occlusion, thrombosis or encasement that extends
      for several centimeters of superior mesenteric vein and portal vein. Tumor abutment,
      encasement or thrombosis of the superior mesenteric artery is also considered unresectable
      disease. Involvement of lymph nodes outside of the area of resection also indicates that the
      patient is not resectable.

      For patients who have unresectable pancreatic ductal adenocarcinoma, chemotherapy and
      radiation can only provide short-term disease control. Chemotherapy and radiation regimens
      have not been shown to prolong survival significantly in this disease, and therefore, there
      is a need for additional adjunctive or consolidative treatment to provide improved local
      control, pain relief and possibly impact survival. Image guided ablation technique like
      irreversible electroporation has shown promise as a new treatment option for patients with
      stage III locally advanced pancreatic cancer.

      A unique advantage of Nanoknife is that it does not require heat to ablate tumor cells,
      rather it works by using high voltage but low energy direct current. The process in which low
      energy direct current ablates tissue is called irreversible electroporation. In order to
      understand how this process works, the investigators have to understand some background cell
      biology. The cell membrane separates the intracellular space and the extracellular
      space/fluid, and controls transport processes between the two compartments of the cell.
      Electroporation increases cell membrane permeability by subjecting it to an electrical field
      and uses rapid series of short electrical pulses delivered using high voltage but low energy
      direct current to create defects (pores) in the cell membrane that result in loss of
      homeostasis and cell death. The result is a well demarcated area of ablation. The Nanoknife
      system comes with 19 gauge needles that have depth markings. The needle surface is echogenic.
      The active electrode length is adjustable in 0.5 cm increments from zero to 4 cm. There is an
      external electrocardiogram synchronization device that automatically detects the R wave and
      energy is delivered synchronously to the R wave. The electrodes can be arranged in multiple
      configurations using two to six electrodes. The spacing between the electrodes can be from
      0.5 cm to 2.0 cm, and electrode exposure can be from 0.5 cm to 4.0 cm. Energy is delivered
      between the electrode pairs, and this results in an area of ablated tissue.

      Nanoknife is particularly useful in patients with pancreatic ductal adenocarcinoma because of
      the proximity of pancreatic tumors to critical surrounding structures such as bile ducts and
      major blood vessels. Because it does not use heat to ablate tissue (which induces necrosis)
      but rather uses cell apoptosis, it theoretically has no impact on the surrounding structures
      that mainly consist of proteins like vascular elastic and collagenous structures as well as
      peri-cellular matrix proteins (protecting large blood vessels and bile ducts). Further study
      of Nanoknife is needed to see if this therapy can potentially impact survival and/or provide
      adequate local palliation to improve quality of life in patients with locally advanced
      unresectable pancreatic ductal adenocarcinoma.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Overall survival

Secondary Outcome

 Complications

Condition

Pancreatic Cancer

Intervention

Nanoknife Irreversible Electroporation

Study Arms / Comparison Groups

 Locally Advanced Pancreatic Cancer
Description:  Patients with locally advanced unresectable pancreatic cancer. Unresectable tumors as defined by:
occlusion, thrombosis or several centimeters of encasement of the superior mesenteric vein or portal vein
tumor abutment greater than 180 degrees of the superior mesenteric artery or thrombosis of the artery
abutment or encasement of the celiac axis
involvement of lymph nodes outside the area of resection

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

Device

Estimated Enrollment

30

Start Date

May 15, 2018

Completion Date

May 2023

Primary Completion Date

May 2023

Eligibility Criteria

        Inclusion Criteria:

          -  age >18

          -  locally advanced unresectable pancreatic ductal adenocarcinoma as demonstrated by CT
             or MRI

          -  must have received standard chemotherapy and completed at least four cycles of
             treatment at least 5 weeks prior to therapy with Nanoknife

          -  INR <1.5

          -  able to tolerate laparotomy (medical/cardiac clearance as needed)

          -  able to comply with protocol requirements

          -  women of childbearing potential must have a negative serum pregnancy test and be
             practicing an effective form of birth control

        Exclusion Criteria:

          -  patients with tumor >5cm after completion of chemotherapy

          -  presence of metastatic disease

          -  patients with a pacemaker or electrostimulator

          -  estimated survival is less than 3 months

          -  presence of a metallic stent (biliary or duodenal) which cannot be removed or
             exchanged for plastic

          -  ECOG performance status more than or equal to 2

          -  epilepsy or other convulsive conditions

          -  cannot tolerate general anesthesia

          -  patients with atrial fibrillation who have an undetectable wave form on the ECG
             synchronization device

          -  patients with inducible ischemia on cardiac stress test or uncontrolled angina

          -  white blood cell count less than or equal to 2,000, absolute neutrophil count <1,000,
             platelets <50,000
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sung Kwon, MD, 201-541-5989, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03614910

Organization ID

holynamenanoknife1


Responsible Party

Sponsor

Study Sponsor

Holy Name Medical Center, Inc.


Study Sponsor

Sung Kwon, MD, Principal Investigator, Holy Name Medical center


Verification Date

September 2019