Early Liver Support With MARS in Post-hepatectomy Liver Failure

NCT ID: NCT03761238

Last Updated: 2018-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2022-09-15

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 in patients with post-hepatectomy liver failure (PHLF).

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 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.

Conditions

Liver Failure as A Complication of Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard medical treatment + MARS

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

Group Type: EXPERIMENTAL

Molecular Adsorbent Recirculating System

Intervention Type: DEVICE

MARS therapy will start within 24-48 h after randomization and be given on 3 consecutive days in sessions of 8-12 h. The patients are observed for 2 days following the last session, with focus on bilirubin INR and signs of encephalopathy, and can thereafter receive 3 additional sessions in case of no or partial response to treatment.

Standard medical treatment

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

Group Type: ACTIVE_COMPARATOR

Standard medical treatment (SMT)

Intervention Type: OTHER

Patient management and standard medical treatment (SMT) as specified in the study protocol.

Interventions

Molecular Adsorbent Recirculating System

MARS therapy will start within 24-48 h after randomization and be given on 3 consecutive days in sessions of 8-12 h. The patients are observed for 2 days following the last session, with focus on bilirubin INR and signs of encephalopathy, and can thereafter receive 3 additional sessions in case of no or partial response to treatment.

Intervention Type: DEVICE

Standard medical treatment (SMT)

Patient management and standard medical treatment (SMT) as specified in the study protocol.

Intervention Type: OTHER

Other Intervention Names

MARS 1116/1 - X-MARS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stefan Gilg, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Stefan Gilg, MD, PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stefan Gilg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Central Contacts

Stefan Gilg, MD PhD

Role: CONTACT

stefan.gilg@ki.se

0702677722 ext. 46

Other Identifiers

ELISH

Identifier Type: -

Identifier Source: org_study_id