Liver Metastasis
Conditions
Keywords
Hepatectomy, Liver metastasis, High-Intensity Focused Ultrasound, Liver metastases (LM) requiring surgery
Brief summary
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.
Interventions
DEVICEPre-coagulation of the liver parenchyma with HIFU
6 to 10 (or more if necessary) side-to-side 40-seconde HIFU treatments
Sponsors
Centre Leon Berard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years at the day of consenting to the study. * Patients with liver metastases requiring a hepatectomy for ≥ 2 segments. * ECOG PS ≤ 1. * Adequate bone marrow and liver function at baseline as defined below: * Platelet count ≥ 100 x 109/l, and hemoglobin of ≥ 9 g/dl), * Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN. * Recovered from prior anti-neoplasic treatment-related toxicity (grade \<2 persistent treatment-related toxicity as per CTCAE v4 are accepted). * Willingness for follow-up visits. * Covered by a medical insurance. * Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
Exclusion criteria
* Patients having previously undergone * a major hepatic surgery (i.e. more than 3 liver segments) or * biliary major surgery. * Patient with cirrhosis or sinusoidal obstruction syndrome with portal hypertension. * Pregnant women (women of childbearing potential are required to have a negative pregnancy test within 72 hours prior to inclusion). A positive urine test must be confirmed by a serum pregnancy test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalized blood loss (ml/cm2) | During hepatectomy | To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total blood los (ml) | During hepatectomy | — |
| Transection time | During hepatectomy | — |
| Transection time/cm2 of liver area (min/cm2) | During hepatectomy | — |
| Hemostasis time | During hepatectomy | — |
| Clip density on the liver section area | During hepatectomy | Number of clips/cm2 |
| Rate of Pringle manoeuvre | During hepatectomy | — |
| Rate of patients needing a blood transfusion | During hepatectomy | — |
| Length of hospital stay | 10 days | — |
| Number of patients with postoperative complications assessed using Dindo-Clavien classification | 6 months | — |
Countries
France
Outcome results
None listed