Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial

Table 2 Trial visits and documented parameters

Visit	1	2	3–4^a	5	6	7–12
Time point	Screening	Day of surgery, pathology	POD 5 POD 10–12	Day of discharge	POD 90	POM 6, 12, 18, 24, 30, 36 (or pre-mature trial termination)
Type of visit	Inpatient	Inpatient	Inpatient	Inpatient	Outpatient (inpatient) (telephone)	Outpatient (telephone)
Written informed consent	X
Preoperative inclusion/exclusion criteria	X
Intraoperative inclusion criteria		X
Demographics and baseline data	X
Medical history	X
Surgery data		X
Randomisation		X
Primary endpoint
Disease-free survival			X	X	X	X
Secondary endpoints
Pathologic data		X
Postoperative morbidity			X	X	X
Length of hospital stay				X
Overall survival			X	X	X	X
Local recurrence			X	X	X	X
Patient-reported outcomes (PRO)
Quality of recovery^c	X		(X)^d
Quality of life assessment^b	X			X		X
Safety
SAE		X	X	X	X	X

POD Postoperative day, POM Postoperative month, PRO Patient-reported outcome, SAE Serious adverse events
^aSkip respective visits if the patient has been discharged prior to visit
^bAccording to EORTC QLQ-C30 and -PAN26
^cAccording to the QoR-15
^dOnly on POD 5

ISSN: 1745-6215