Early Liver Support With MARS in Post-hepatectomy Liver Failure (ELISH)

Stefan Gilg, MD, PhD

Status: Unknown

Conditions: Liver Failure as A Complication of Care

Treatments: Other: Standard medical treatment (SMT); Device: Molecular Adsorbent Recirculating System

Study type: Interventional

Funder types: Other

Identifiers

NCT03761238

ELISH

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

44 participants in 2 patient groups

Standard medical treatment + MARS

Experimental group

Description:

Patients assigned to the control arm will receive standard medical treatment (SMT) and liver dialysis using Molecular Adsorbent Recirculating System (MARS).

Treatment:

Device: Molecular Adsorbent Recirculating System

Standard medical treatment

Active Comparator group

Description:

Patients assigned to the control arm will receive standard medical treatment (SMT) as specified in the study protocol.

Treatment:

Other: Standard medical treatment (SMT)