Table 1.
Schedule of study enrolment, interventions, and assessments
Time point | Study period | ||||||||||||||||
Enrolment | Allocation | Treatment | Discharge | Post-allocation | Close-out | ||||||||||||
Outpatient clinic /Admission | Before Surgery | Surgery | After Surgery | Month 1 (T1) |
Month 3 (T2) |
Month 6 (T3) |
Month 9 (T4) |
Month 12 (T5) |
Month 18 (T6) |
Month 24 (T7) |
Month 30 (T8) |
Month 36 (T9) |
Month 42 (T10) |
Month 48 (T11) |
Month 54 (T12) |
Month 60 (T13) |
|
Enrolment | |||||||||||||||||
Eligibility screen | × | ||||||||||||||||
Informed consent | × | ||||||||||||||||
Allocation | × | ||||||||||||||||
Interventions | |||||||||||||||||
LPD | × | ||||||||||||||||
OPD | × | ||||||||||||||||
Assessments | |||||||||||||||||
Baseline characteristics | × | ||||||||||||||||
Blood routine | × | × | × | × | × | × | × | × | × | × | × | × | × | × | |||
Blood biochemistry | × | × | × | × | × | × | × | × | × | × | × | × | × | × | |||
Tumour marker | × | × | × | × | × | × | × | × | × | × | × | × | × | × | |||
Abdominal CT scan | × | × | × | × | × | × | × | × | × | × | × | × | × | × | |||
Surgical record | × | ||||||||||||||||
Postoperative record | × | ||||||||||||||||
Pathological findings | × | ||||||||||||||||
Adjuvant therapy | × | × | × | × | × | × | × | × | × | × | × | × | × | ||||
Survival status | × | × | × | × | × | × | × | × | × | × | × | × |
LPD, laparoscopic pancreaticoduodenectomy; OPD, open pancreaticoduodenectomy.