Irreversible Electroporation for treatment of unresectable, locally advanced pancreatic cancer in the Leiden University Medical Centre: a phase I/II study.
- Conditions
- carcinoma of the pancreaspancreatic cancer1001981510019818
- Registration Number
- NL-OMON40396
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
Pre-operative inclusion criteria
• 18 years of age
• Tumor in the pancreas suspected for adenocarcinoma according to diagnostic set in the national guideline*
• Based on preoperative imaging the tumor is judged as resectable in the multidisciplinary meeting, but is also shown to have at least abutment of a venous vascular structure (portal vein, superior mesenteric vein) (see table 1 in Appendix A)
• Tumor size must be < 4 cm at the time of IRE treatment and must be measurable
• Karnofsky Performance Status score of >70% or ECOG of 0 to 1
• INR < 1.3
• ANC > 1.5x109/L
• Hemoglobin >6mmol/L
• Platelets > 100x109/L
• Renal function: eGFR >50ml/min
• Bilirubin level <250mmol/L
• Willing and able to comply with the protocol requirements
• Able to comprehend and have signed an Informed Consent Form (ICF) to participate in the study
* Suspected tumor in the pancreas on US and CT/MR, or, if necessary, followed by endoscopic ultrasound or ERCP with or without cytological and/or histological diagnosis (www.oncoline.nl/pancreascarcinoom).;Per-operative inclusion criteria
• Unresectable during intraoperative ultra sound investigation after minimal surgical exploration:
• Extensive tumor growth around superior mesenteric vein and their side-branches (see table 2 in Appendix A).
• Involvement of arterial structures (see table 2 in Appendix A)
• Per-operative diagnosis confirmed by frozen section analysis
• Contraindications for laparotomy or IRE
• Resectable at laparotomy
• Evidence of distant metastases (pre or per-operative) including cytological proven N2 metastases
• Stenosis >50% of Common Hepatic Artery and/or Celiac Trunc
• Inability to stop anticoagulant therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
• Known history of contrast allergy that cannot be medically managed
• Women who are pregnant or currently breast feeding
• Women of child bearing potential who are not willing to use hormonal contraception or intrauterine device (IUD) during the study
• Have a cardiac pacemaker or defibrillator
• Have metal parts in the vicinity of lesions to be ablated at the time of treatment with the NanoKnife System
• Recent history of myocardial infarction (within the past 3 months)
• Patients with a history of Epilepsy
• Patients with a current history of clinically significant Cardiac Arrhythmia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and feasibility of the procedure</p><br>
- Secondary Outcome Measures
Name Time Method <p>Tumor downstaging<br /><br>VAS pain score<br /><br>Hospital stay (days)<br /><br>Immunological effects</p><br>