Table 2

Trial visits and assessment of endpoints

DocumentationVisit 1Visit 2Visit 3Visit 4–6Visit 7Visit 8Visit 9Visit 10Visit 11–13
ScreeningDay before surgeryDay of surgery 10–28 days after V1POD 1/3/5POD 7POD 14/dischargePOD 303 months6/12/24 months
Eligibility criteriaXX
Baseline data, demographicsX
Previous medicationX
Assessment of safetyXXXXXXX
Secondary endpoints*XXXXX
Routine blood sampling‡XXXXX
Blood sampling translational testsXXXXX
Tissue samplingX
  • *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.