Treatment of unresectable Locally Advanced Pancreas cancer with Percutaneous Irreversible Electroporation following initial systemic chemotherapy (LAP-PIE): a randomised controlled feasibility trial

Royal Free London NHS Foundation Trust0 个研究点目标入组 50 人开始时间: 2021年2月9日最近更新: 2024年1月22日

适应症

试验速览

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35551086/ (added 16/05/2022)

•1. Able to provide informed consent
•2. Aged =18 years
•3. Locally advanced pancreatic cancer anywhere in the pancreas
•3. Tissue confirmation of pancreatic adenocarcinoma by biopsy or cytology/pathology
•4. Cancer not amenable to surgical resection (following pancreas surgeon/multidisciplinary team review)
•5. Completed systemic chemotherapy with FOLFIRINOX (standard or modified ). This must be the only regimen of chemotherapy the patient has had since diagnosis.
•6. Considered amenable to irreversible electroporation (IRE) therapy by pancreas interventional radiologist
•7. WHO Performance status 0 or 1
•8. Maximum cancer diameter 3.5 cm at the time of IRE treatment
•9. Considered fit for general anaesthetic following pre-assessment.

•1. First line chemotherapy other than FOLFIRINOX
•2. Concomitant malignancy (except skin and prostate cancers)
•3. Metastatic disease including distant (i.e. non-local) nodal metastases
•4. Borderline resectable disease
•5. Occlusion or >180° involvement of the portal vein (superior mesenteric vein/portal vein)
•6. Arterial involvement with <180° of the superior mesenteric artery, celiac axis, or common hepatic artery
•7. Untreated gastric outlet or biliary obstruction
•8. Co-morbidity precluding general anaesthesia
•9. Indwelling electrical devices such as pacemakers and Left Ventricular Assist Devices (LVADs)
•10. Chronic Kidney Disease stage 3, 4, or 5
•11. History of epilepsy or other neurological diseases
•12. Abdominal varices preventing safe access to pancreas cancer
•13. Unable to tolerate general anaesthetic with neuromuscular blockade
•14. Subjects who are actively bleeding, anticoagulation which cannot be discontinued, coagulopathy defined as an international normalized ratio (INR) of =1.5, or have any one of the following haematology results:
•14.1. Haemoglobin <8 g/dl
•14.2. Absolute neutrophil count <1500 cells/ml
•14.3. Platelet count <50,000.

发起方