Status:
TERMINATED
Efficacy of HIFU-AR on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy
Lead Sponsor:
Centre Leon Berard
Conditions:
Liver Metastasis
Eligibility:
All Genders
18+ years
Phase:
NA
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, m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02728167
Start Date
April 1 2016
End Date
August 1 2018
Last Update
August 15 2018
Active Locations (1)
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1
Centre Léon Bérard
Lyon, France, 69373