Locally advanced unresectable pancreatic cancer, alvleesklierkanker, lokaal uitgebreid
Conditions
Interventions
Irreversible electroporation (IRE) is a new ablation technique. By changing the electric potential across the cell membrane, the lipid bilayer is disrupted and becomes porous. With high voltages, appl
Sponsors
Leiden University Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 years of age; 2. Tumour in the pancreas suspected for adenocarcinoma; 3. Based on preoperative imaging the tumor is judged as resectable in the multidisciplinary meeting, but is also shown to have at least abutment of venous vascular structures (portal vein, superior mesenteric vein) (see table 1 in Appendix A); 4. Tumour size must be 80% or ECOG of 0 to 1; 6. INR 1.5x109/L; 8. Bilirubin level <250mmol/L otherwise drainage is performed and surgery is posponed until bilirubin levels have returned to normal; 9. Willing and able to comply with the protocol requirements; 10. Able to comprehend and have signed an Informed Consent Form (ICF) to participate in the study. Inclusion criteria: per-operative inclusion criteria 1. Unresectable during intraoperative ultra sound investigation after minimal surgical exploration: a. Extensive tumour growth around superior mesenteric vein and their side-branches (see table 2 in Appendix A). b. Involvement of arterial structures c. Per-operative diagnosis confirmed by frozen section analysis
Exclusion criteria
Exclusion criteria: 1. Contraindications for laparotomy or IRE 2. Resectable at laparotomy 3. Evidence of distant metastases (pre or per-operative) 4. Screening creatinine reported as > 2.3 mg/dL 5. Inability to stop anticoagulant therapy for 7 days prior to and 7 days post treatment with the NanoKnife System 6. Known history of contrast allergy that cannot be medically managed 7. Women who are pregnant or currently breast feeding 8. Women of child bearing potential who are not willing to use hormonal contraception or intrauterine device (IUD) during the study 9. Have a cardiac pacemaker or defibrillator 10. Have metal parts in the vicinity of lesions to be ablated at the time of treatment with the NanoKnife System 11. Recent history of myocardial infarction (within the past 3 months) 12. Patients with a history of Epilepsy 13. Patients with a current history of clinically significant Cardiac Arrhythmia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and feasibility of the procedure. The safety is checked by reporting adverse events, also the first 5 procedures will be filmed. The feasibility is measured by evaluating specific questions about procedure and technical aspects. This is evaluated after every procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Local progression free survival, based on CT scans. Once pre-procedural, than 5days after, 3,6,9,12,18,24 months after the procedure. - Overall survival in days - day of surgery untill day of death - Tumour downstaging/follow-up of local situation, based on repeated CT scans - NRS pain score; this will be measured daily post-operative. Outcomes will be compared with a control group of patients treated before this trial. - Hospital stay (days: form day of procedure till day of discharge) - Tumour response related to immune defence (blood samples). Once pre-procedural, than 5days after, 3,6,9,12,18,24 months after the procedure. - Quality of life; as measured by EORTC questionnaire. Once pre-procedural, than 3,9, 18 months after the procedure. | — |
Contacts
Public ContactE.M. de Leede
Outcome results
None listed