Irreversible Electroporation for treatment of unresectable, locally advanced pancreatic cancer in the Leiden University Medical Centre: a phase I/II study. - IRE for unresectable pancreatic carcinoma the LUMC

eids Universitair Medisch Centrum0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

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•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

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