Status:
UNKNOWN
Early Liver Support With MARS in Post-hepatectomy Liver Failure
Lead Sponsor:
Stefan Gilg, MD, PhD
Conditions:
Liver Failure as A Complication of Care
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a prospective, randomized, open-label, multicentre study involving European centers with experience in the management of PHLF to assess the impact of early liver support with MARS on survival ...
Detailed Description
PHLF is a major risk factor for mortality in patients who underwent major hepatectomy. A specific treatment is yet not available. In a primary proof-of-concept study, it was shown that it is safe and ...
Eligibility Criteria
Inclusion
- Patients subjected for major liver surgery (4 or more Couinaud segments) or patients undergoing a 2nd, 3rd or 4th hepatic resection. Pre-operative chemotherapy and/or biological agents are allowed.
- Primary PHLF occurring early after surgery defined by the 50:50 criteria (from PO day 5 to day 14) or by the presence of hepatic encephalopathy grade 2 or more and the 50:50 criteria (from PO day 3 to 4).
- Written informed consent.
Exclusion
- ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) procedure.
- In patients with chronic liver disease presence of significant portal hypertension (hepatic venous pressure gradient ≥ 10 mmHg and/or Fibroscan ≥ 21kPa) prior to surgical intervention.
- Any contraindication for MARS therapy such as uncontrolled active bleeding, platelet counts \<20.000 /µl or uncontrolled infection (presence of fever or adequate antibiotic therapy for less than 48h), septic shock, haemodynamic instability requiring inotropic support (noradrenaline \> 1mg/h).
- PHLF occurring after post operative day 14.
- Secondary PHLF: post-operative liver failure secondary to vascular (outflow or inflow thrombosis) or septic problems.
- Persistant biliary complications (infected biloma, main biliary tree damage).
- Inability or unwilling of the patient or family to give informed consent.
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03761238
Start Date
March 15 2019
End Date
September 15 2022
Last Update
December 3 2018
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