Table 1

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

TimepointStudy period
EnrolmentAllocationPost-allocation follow-up time pointsClose-out
-t1 0 Pre-IRE 6 hours post-IRE 6 days post-IRE 3 months 6 months 9 months 12 months
Enrolment:
 Eligibility screenX
 PIS givenX
Systemic treatment with FOLFIRINOX X
sMDT X
Informed consent X
 AllocationX
Interventions:
IRE (intervention) Embedded Image
Systemic chemotherapy (SoC) Embedded Image
Assessments:
CT CAP XXXXX
Blood tests XXXXXXXXX
HRQoL XXXXX
Complications XXXXX
  • 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.