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Table 3 SPIRIT flow diagram

From: 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

 BaselineLiver preparationAfter liver preparationSurgerybPost-op follow-up
 TreatmentDuring hospitalizationWeek 1Week 3Every 2 weeks or week 7During hospitalizationWeek 4Day 90
D-30 – D0D-8 – D0D0Each dayaD0 + 7 days
(+/− 1 day)
D0 + 21 days
(+/−  1 day)
 Each daycSurgery + 28 days (+/−  1 day)Surgery + 90 days (+/−  1 day)
Inclusion/exclusion criteriaXX        
Written consentX         
Medical historyX         
Clinical evaluationX  XXXXXXX
ECOG performance statusX  XXXXXXX
Prior/concomitant medicationsX  XXXXXXX
Biological evaluation X XfXXXXgXX
Serum pregnancy X        
Biological collection (translational research)  XdXdX  Xe  
Liver biopsy (translational research)  X    Xh  
99 m-Tc mebrofenin scintigraphy (translational research)X   XXX X 
Spiral CT/MRI of abdomenX   XXX XX
Randomization X        
Liver venous deprivation/portal vein embolization  X       
Adverse events/Serious adverse events   XXXXXXX
  1. a Before and after liver preparation
  2. 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)
  3. c Before and after surgery
  4. 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
  5. e The samples of the translational study are to be done the day of surgery
  6. f Biological evaluation are to be done 6 h after treatment
  7. g Biological evaluation are to be done the day before surgery, 6 h and 12 h after surgery, then daily during hospitalization
  8. h Biopsy of the deportalized lobe and FLR are to be done the day of surgery