Post Hepatectomy Liver Failure Clinical Trial
Official title:
Early Postoperative Extracorporal Liver Support Therapy (ELS) as a Tool to Manage Post Hepatectomy Liver Failure (PLF)
| Verified date | January 2019 |
| Source | Karolinska University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | November 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Department of Surgery Gastrocentrum Karolinska Univeristy Hospital | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska University Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of PLF patients who develop serious adverse events during ELS according to SOFA scores and Westhaven criteria | At least five sessions of Mars. SOFA (score 1-4). | First two weeks postoperatively after major hepatectomy | |
| Primary | Number of PLF patients who develop serious adverse events during ELS | At least five sessions of Mars. Westhaven (criteria 1-4) | First two weeks postoperatively after major hepatectomy | |
| Secondary | The predictive value of liver enzymes and bilirubin changes as marker of liver failure | At least five sessions of Mars. Liver enzymes measured( liver transaminases microkat/L ), bilirubin (mmol/L) | First two weeks postoperatively after major hepatectomy | |
| Secondary | Portal flow (ml/minute) before and during ELS | At least five sessions of Mars | First two weeks postoperatively after major hepatectomy | |
| Secondary | To assess liver function by use of Indocyanine green clearance (ICG)(% clearance/unit time) under ELS treatment | At least five sessions of Mars | First two weeks postoperatively after major hepatectomy | |
| Secondary | Portal pressure (cmH2O) before and during ELS | At least five sessions of Mars | First two weeks postoperatively after major hepatectomy |