Table 1

Schedule of enrolment, interventions and assessments of the LAP-PIE trial

TimepointStudy period
EnrolmentAllocationPost-allocation follow-up time pointsClose-out
-t10Pre-IRE6 hours post-IRE6 days post-IRE3 months6 months9 months12 months
Enrolment:
 Eligibility screenX
 PIS givenX
Systemic treatment with FOLFIRINOXX
sMDTX
Informed consentX
 AllocationX
Interventions:
IRE (intervention)Embedded Image
Systemic chemotherapy (SoC)Embedded Image
Assessments:
CT CAPXXXXX
Blood testsXXXXXXXXX
HRQoLXXXXX
ComplicationsXXXXX
  • 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.