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NCT Number: NCT03011424

Early Postoperative Extracorporal Liver Support Therapy (ELS) as a Tool to Manage Post Hepatectomy Liver Failure (PLF)

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

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Key information

Conditions

Post Hepatectomy Liver Failure Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery Gastrocentrum Karolinska Univeristy Hospital

Stockholm, 14186, Sweden

About this study

Primary issues to be addressed

  • Can ELS be applied in an early phase of PLF?
  • Is ELS safe and feasible for the treatment of PLF when practised according to a predefined protocol?

Secondary issues to be addressed

  • The development of predictive laboratory-chemical markers of liver failure
  • Indirect measures of portal flow and portal pressure
  • Indocyanine green clearance (ICG) under ELS treatment
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 70 years
  • Patients subjected for major liver surgery (4 or more Couinaud segments, ca. 50 % or more of total liver volume)
  • Pre-operative chemotherapy and/or biological agents are allowed
  • Liver cirrhosis Child Pugh Score A is allowed

Exclusion criteria

  • Any contra indication for ELS such as uncontrolled active bleeding or platelet counts <20.000 /µl
  • Macroscopic liver cirrhosis (Child Pugh Score B and C)
  • Inability or unwilling to give informed consent

Treatment and study plan

Extracorporeal liver support therapy (ELS)

Device

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.

Primary outcomes

  1. Number of PLF patients who develop serious adverse events during ELS according to SOFA scores and Westhaven criteria

    Time frame: First two weeks postoperatively after major hepatectomy

    At least five sessions of Mars. SOFA (score 1-4).

  2. Number of PLF patients who develop serious adverse events during ELS

    Time frame: First two weeks postoperatively after major hepatectomy

    At least five sessions of Mars. Westhaven (criteria 1-4)

Secondary outcomes

  1. The predictive value of liver enzymes and bilirubin changes as marker of liver failure

    Time frame: First two weeks postoperatively after major hepatectomy

    At least five sessions of Mars. Liver enzymes measured( liver transaminases microkat/L ), bilirubin (mmol/L)

  2. Portal flow (ml/minute) before and during ELS

    Time frame: First two weeks postoperatively after major hepatectomy

    At least five sessions of Mars

  3. To assess liver function by use of Indocyanine green clearance (ICG)(% clearance/unit time) under ELS treatment

    Time frame: First two weeks postoperatively after major hepatectomy

    At least five sessions of Mars

  4. Portal pressure (cmH2O) before and during ELS

    Time frame: First two weeks postoperatively after major hepatectomy

    At least five sessions of Mars

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2017
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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