NCT03011424

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Post Hepatectomy Liver Failure

Interventions

Type	Name	Description
DEVICE	Extracorporeal liver support therapy (ELS)	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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-05-01
• Completion: 2015-11-01
• First posted: 2017-01-05
• Last updated: 2019-01-04

Locations

1 site across 1 country: Sweden