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

NCT03614910 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-08-03

No results posted yet for this study

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

Interventions

DEVICE

Nanoknife Irreversible Electroporation

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

Sponsors & Collaborators

  • Holy Name Medical Center, Inc.

    lead OTHER

Principal Investigators

  • Sung Kwon, MD · Holy Name Medical center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03614910 on ClinicalTrials.gov