The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
6 to 10 (or more if necessary) side-to-side 40-seconde HIFU treatments
Centre Léon Bérard
Lyon, France
Normalized blood loss (ml/cm2)
To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection
Time frame: During hepatectomy
Total blood los (ml)
Time frame: During hepatectomy
Transection time
Time frame: During hepatectomy
Transection time/cm2 of liver area (min/cm2)
Time frame: During hepatectomy
Hemostasis time
Time frame: During hepatectomy
Clip density on the liver section area
Number of clips/cm2
Time frame: During hepatectomy
Rate of Pringle manoeuvre
Time frame: During hepatectomy
Rate of patients needing a blood transfusion
Time frame: During hepatectomy
Length of hospital stay
Time frame: 10 days
Number of patients with postoperative complications assessed using Dindo-Clavien classification
Time frame: 6 months
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