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

NCT03614910 | Completed

• 1 other identifier: holynamenanoknife1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Locally advanced pancreatic cancer; irreversible electroporation; Nanoknife

Outcome Measures

Primary Outcomes (4)

• Overall survival

  Time from Nanoknife treatment to the patient's death

  up to 10 years

• Local progression-free survival

  Time from Nanoknife treatment to local disease progression

  up to 10 years

• Distant disease-free survival

  Time from Nanoknife treatment until distant disease development

  up to 10 years

• Tumor response

  Change in tumor size in response to Nanoknife treatment using RECIST criteria V1.1 (CR, PR, SD, PD)

  First year

Secondary Outcomes (5)

• Complications

  90 days

• Tumor Markers

  up to 10 years

• Biliary Obstruction

  up to 10 years

• Gastric outlet obstruction

  up to 10 years

• Cancer related pain

  up to 10 years

Study Arms (1)

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

Interventions

Nanoknife Irreversible Electroporation DEVICE

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

Locally Advanced Pancreatic Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Holy Name Medical Center, Inc.: lead

Study Sites (1)

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Sung Kwon, MD

  Holy Name Medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 3, 2018
• Study Start: May 15, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)