Early Postoperative Extracorporal Liver Support Therapy (ELS) as a Tool to Manage Post Hepatectomy Liver Failure (PLF)
Condition: Post Hepatectomy Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency
Study type: Interventional

Summary: 
      Early postoperative extracorporal liver support therapy (ELS) as a tool to manage post
      hepatectomy liver failure (PLF).

      Post-operative liver failure (PLF) has been identified as a major risk factor leading to
      increased morbidity and mortality. The incidence of PLF varies largely between 0-30%, and may
      be accounted for the main reason of postoperative mortality related to liver surgery
      (reported figures ranging from 18 to 75 %).

      Currently, there are only a few treatment options for PLF, mainly restricted to the treatment
      of complications like bile leakage, infections as well as the prevention of further liver
      damage caused by e.g. thrombosis or haemorrhage as well as administration of liver toxic
      drugs. Recently the international study group on liver surgery (ISGLS) published criteria for
      a new definition of PLF which will greatly facilitate the comparison of results from future
      studies on a variety of aspects on liver failure.

      ELS by using the Molecular Adsorbent Recirculating System (MARS) is based on a modified
      haemodialysis that allows the removal of water-soluble and protein bound toxins over an
      albumin-coated high flux membrane against recycled exogenous albumin. Thus, MARS can support
      the compromised detoxification capacity of the liver as well as improve physiological
      parameters. This would offer the potential for temporary support for the harmed liver after
      liver resection allowing for a more uneventful recovery.

      For obvious reasons previous reports contain few patients, present heterogonous treatment
      groups and all suffer from lack of standardized treatment protocols. Few if any surviving
      patients, thus providing no evidence to encourage ELS as a possible treatment option for
      patients suffering of PLF. However, studies with defined patient populations and treatments
      according to a predefined standardised treatment protocol are warranted.

      Primary issues to be addressed:

        1. Can ELS be applied in an early phase of PLF?

        2. Is ELS safe and feasible for the treatment of PLF when practised according to a
           predefined protocol?

      Secondary issues to be addressed:

        1. The development of predictive laboratory-chemical markers of liver failure

        2. Indirect measures of portal flow and portal pressure

        3. Indocyanine green clearance (ICG) under ELS treatment

        4. Clearance of toxic products as assessed in aliquots taken from the dialysate
    

Detailed description: 
      Primary issues to be addressed

        1. Can ELS be applied in an early phase of PLF?

        2. Is ELS safe and feasible for the treatment of PLF when practised according to a
           predefined protocol?

      Secondary issues to be addressed

        1. The development of predictive laboratory-chemical markers of liver failure

        2. Indirect measures of portal flow and portal pressure

        3. Indocyanine green clearance (ICG) under ELS treatment

        4. Clearance of toxic products as assessed in aliquots taken from the dialysate

      Design

        -  Prospective phase 1 safety and feasibility study

      Study Population

        -  10 consecutive patients being subjected to extended liver surgery (at least right sided
           or extended right/left sided hemihepatectomy)
    

Intervention name(s): Extracorporeal liver support therapy (ELS)
Intervention type(s): Device
Intervention description(s): ELS by using the Molecular Adsorbent Recirculating System (MARS) is based on a modified haemodialysis that allows the removal of water-soluble and protein bound toxins over an albumin-coated high flux membrane against recycled exogenous albumin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver resection; post hepatectomy liver failure; liver dialysis; encephalopathy; mortality