Trial visits and assessment of endpoints
| Documentation | Visit 1 | Visit 2 | Visit 3 | Visit 4–6 | Visit 7 | Visit 8 | Visit 9 | Visit 10 | Visit 11–13 |
| Screening | Day before surgery | Day of surgery 10–28 days after V1 | POD 1/3/5 | POD 7 | POD 14/discharge | POD 30 | 3 months | 6/12/24 months | |
| Eligibility criteria | X | X | |||||||
| Baseline data, demographics | X | ||||||||
| Randomisation | X | ||||||||
| Previous medication | X | ||||||||
| Assessment of safety | X | X | X | X | X | X | X | ||
| Feasibility/adherence | X | X | X | X | X | X | X | ||
| Secondary endpoints* | X | X | X | X | X | ||||
| Survival/recurrence | X† | X† | X† | X† | X† | X† | X | X | |
| Routine blood sampling‡ | X | X | X | X | X | ||||
| Blood sampling translational tests | X | X | X | X§ | X | X | |||
| Tissue sampling | X |
*Details of surgery, pathological results (TNM stage), pancreas specific complications.
†Only survival.
‡Blood count, CRP, creatinin, bilirubin, albumin, international normalised ratio, CEA, CA 19–9 (visit 1 and/or 2, 10), pregnancy test in case of childbearing potential (visit 1).
§POD 1 and 3 only.
CA, carbohydrate antigen; CEA, carcinoembryonic antigen; CRP, C reactive protein; POD, postoperative days.