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

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ClinicalTrials.gov Identifier: NCT03614910
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Holy Name Medical Center, Inc.

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.


Condition or disease Intervention/treatment
Pancreatic Cancer Device: Nanoknife Irreversible Electroporation

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Ablation of Unresectable Locally Advanced Pancreatic Cancer With Nanoknife Irreversible Electroporation (IRE) System: Response and Tolerability
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Locally Advanced Pancreatic Cancer

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
Device: Nanoknife Irreversible Electroporation
Irreversible electroporation will be delivered between electrodes that are placed by intraoperative ultrasound guidance around the tumor




Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 10 years ]
    Time from Nanoknife treatment to the patient's death

  2. Local progression-free survival [ Time Frame: up to 10 years ]
    Time from Nanoknife treatment to local disease progression

  3. Distant disease-free survival [ Time Frame: up to 10 years ]
    Time from Nanoknife treatment until distant disease development

  4. Tumor response [ Time Frame: First year ]
    Change in tumor size in response to Nanoknife treatment using RECIST criteria V1.1 (CR, PR, SD, PD)


Secondary Outcome Measures :
  1. Complications [ Time Frame: 90 days ]
    The incidence of the following complications after treatment with Nanoknife will be recorded: hematologic, ileus, bile leak, portal vein thrombosis, deep vein thrombosis, pulmonary, renal failure, ascites, wound infection, dehydration/failure to thrive/nausea, bleeding, diarrhea, duodenal leak, liver insufficiency, pancreatic leak

  2. Quality of Life [ Time Frame: up to 10 years ]
    Treatment related quality of life changes will be measured using the WHOQOL-BREF assessment at each follow-up visit

  3. Tumor Markers [ Time Frame: up to 10 years ]
    CA 19-9 will be measured at 6 weeks post op, 3 months post op, 6 months post op, 1 year post op, then yearly

  4. Biliary Obstruction [ Time Frame: up to 10 years ]
    Change in biliary obstruction after treatment will be recorded using total bilirubin and conjugated/unconjugated bilirubin levels at each follow up office visit

  5. Gastric outlet obstruction [ Time Frame: up to 10 years ]
    Gastric outlet obstruction after treatment will be monitored with symptoms resulting in decreased oral intake (nausea, vomiting, and inability to eat). Objectively we will also measure patient weight in kilograms at each office visit.

  6. Cancer related pain [ Time Frame: up to 10 years ]
    Cancer related pain after treatment will be measured using Visual Analog Pain scale 0-10, zero being no pain and 10 being worst pain possible. Pain scale will be assessed at each follow up visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with locally advanced unresectable pancreatic cancer who meet the criteria for Nanoknife and are able to safely undergo a laparotomy.
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

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): NCT03614910


Contacts
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Contact: Sung Kwon, MD 201-541-5989 steve-kwonmd@mail.holyname.org
Contact: Julie Schwegman, PAC 201-541-5989 schwegman@holyname.org

Locations
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United States, New Jersey
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Sung Kwon, MD    201-541-5989    steve-kwonmd@mail.holyname.org   
Contact: Julie Schwegman, PAC    201-541-5989    schwegman@holyname.org   
Sponsors and Collaborators
Holy Name Medical Center, Inc.

Additional Information:

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Responsible Party: Holy Name Medical Center, Inc.
ClinicalTrials.gov Identifier: NCT03614910     History of Changes
Other Study ID Numbers: holynamenanoknife1
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Holy Name Medical Center, Inc.:
Locally advanced pancreatic cancer
irreversible electroporation
Nanoknife

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