Timepoint | Study period | |||||||||
Enrolment | Allocation | Post-allocation follow-up time points | Close-out | |||||||
-t1 | 0 | Pre-IRE | 6 hours post-IRE | 6 days post-IRE | 3 months | 6 months | 9 months | 12 months | ||
Enrolment: | ||||||||||
Eligibility screen | X | |||||||||
PIS given | X | |||||||||
Systemic treatment with FOLFIRINOX | X | |||||||||
sMDT | X | |||||||||
Informed consent | X | |||||||||
Allocation | X | |||||||||
Interventions: | ||||||||||
IRE (intervention) | ||||||||||
Systemic chemotherapy (SoC) | ||||||||||
Assessments: | ||||||||||
CT CAP | X | X | X | X | X | |||||
Blood tests | X | X | X | X | X | X | X | X | X | |
HRQoL | X | X | X | X | X | |||||
Complications | X | X | X | X | X |
CT CAP, CT chest abdomen pelvis; FOLFIRINOX, 5-FluoroUracil, Leucovorin, Irinotecan and Oxaliplatin; HRQoL, health-related quality of life; IRE, irreversible electroporation; LAP-PIE, locally advanced pancreatic cancer with percutaneous irreversible electroporation; PIS, patient information sheet; sMDT, specialist multidisciplinary team; SoC, standard of care.