Study protocol of the HYPER-LIV01 trial: a multicenter phase II, prospective and randomized study comparing simultaneous portal and hepatic vein embolization to portal vein embolization for hypertrophy of the future liver remnant before major hepatectomy for colo-rectal liver metastases

Table 3 SPIRIT flow diagram

	Baseline		Liver preparation		After liver preparation			Surgery^b	Post-op follow-up
			Treatment	During hospitalization	Week 1	Week 3	Every 2 weeks or week 7	During hospitalization	Week 4	Day 90
	D-30 – D0	D-8 – D0	D0	Each day^a	D0 + 7 days (+/− 1 day)	D0 + 21 days (+/− 1 day)		Each day^c	Surgery + 28 days (+/− 1 day)	Surgery + 90 days (+/− 1 day)
Inclusion/exclusion criteria	X	X
Written consent	X
Demographics	X
Medical history	X
Clinical evaluation	X			X	X	X	X	X	X	X
ECOG performance status	X			X	X	X	X	X	X	X
Prior/concomitant medications	X			X	X	X	X	X	X	X
Biological evaluation		X		X^f	X	X	X	X^g	X	X
Serum pregnancy		X
Biological collection (translational research)			X^d	X^d	X			X^e
Liver biopsy (translational research)			X					X^h
99 m-Tc mebrofenin scintigraphy (translational research)	X				X	X	X		X
Spiral CT/MRI of abdomen	X				X	X	X		X	X
Randomization		X
Liver venous deprivation/portal vein embolization			X
Adverse events/Serious adverse events				X	X	X	X	X	X	X

^a Before and after liver preparation
^b Surgery to be performed ≤8 days after the last 99 m-Tc mebrofenin scintigraphy and CT-scan/MRI (except is surgery is performed after week 8)
^c Before and after surgery
^d The samples of the translational study are to be done the day of the treatment then to D1, D2 and D3 after the treatment. D2 and D3 are optional as soon as the patient is discharged
^e The samples of the translational study are to be done the day of surgery
^f Biological evaluation are to be done 6 h after treatment
^g Biological evaluation are to be done the day before surgery, 6 h and 12 h after surgery, then daily during hospitalization
^h Biopsy of the deportalized lobe and FLR are to be done the day of surgery

ISSN: 1471-2407