Early Liver Support With MARS in Post-hepatectomy Liver Failure
Early Liver Support With MARS in Post-hepatectomy Liver Failure
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 in patients with post-hepatectomy liver failure (PHLF).
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 feasible to use MARS in patients with PHLF early after hepatectomy.
 Survival was superior to a historical control group.

 This study will include patients with early, primary PHLF (based on the 50:50 criteria) after
 major liver surgery. Patients will be randomized 1:1 to receive standard treatment alone or
 standard treatment + liver dialysis using the Molecular Adsorbent Recirculating System
 (MARS). Relevant outcome along with several physiological parameters will be assessed.
Inclusion Criteria:

 -  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 Criteria:

 -  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.