Ablation of Unresectable Locally Advanced Pancreatic Cancer With Irreversible Electroporation (IRE) System
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|ClinicalTrials.gov Identifier: NCT03614910|
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : September 24, 2019
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|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||30 participants|
|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|
Locally Advanced Pancreatic Cancer
Patients with locally advanced unresectable pancreatic cancer. Unresectable tumors as defined by:
Device: Nanoknife Irreversible Electroporation
Irreversible electroporation will be delivered between electrodes that are placed by intraoperative ultrasound guidance around the tumor
- Overall survival [ Time Frame: up to 10 years ]Time from Nanoknife treatment to the patient's death
- Local progression-free survival [ Time Frame: up to 10 years ]Time from Nanoknife treatment to local disease progression
- Distant disease-free survival [ Time Frame: up to 10 years ]Time from Nanoknife treatment until distant disease development
- Tumor response [ Time Frame: First year ]Change in tumor size in response to Nanoknife treatment using RECIST criteria V1.1 (CR, PR, SD, PD)
- 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
- 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
- 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614910
|Contact: Sung Kwon, MDemail@example.com|
|Contact: Julie Schwegman, PACfirstname.lastname@example.org|
|Principal Investigator:||Sung Kwon, MD||Holy Name Medical center|