NCT03614910

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

Completed Last updated 3 August 2022

What this trial tests

trial testing Nanoknife Irreversible Electroporation in Pancreatic Cancer in 30 participants. Completed in 1 May 2021.

Timeline

15 May 2018

Primary endpoint
1 May 2021

1 May 2021

Quick facts

Lead sponsor	Holy Name Medical Center, Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	15 May 2018
Primary completion	1 May 2021
Estimated completion	1 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Nanoknife Irreversible Electroporation

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Holy Name Medical Center, Inc.

Who can join

18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Locoregional therapies and their effects on the tumoral microenvironment of pancreatic ductal adenocarcinoma.
   Lambin T, Lafon C, Drainville RA, Pioche M, et al · · 2022 · cited 13× · PMID 35645539 · DOI 10.3748/wjg.v28.i13.1288
2. Minimally invasive image-guided therapy of primary and metastatic pancreatic cancer.
   Bibok A, Kim DW, Malafa M, Kis B. · · 2021 · cited 9× · PMID 34366607 · DOI 10.3748/wjg.v27.i27.4322
3. Are Aspects of Integrative Concepts Helpful to Improve Pancreatic Cancer Therapy?
   Oei SL, Schad F. · · 2023 · cited 5× · PMID 36831465 · DOI 10.3390/cancers15041116