Post Hepatectomy Liver FailureNCT03011424
Early Postoperative Extracorporal Liver Support Therapy (ELS) as a Tool to Manage Post Hepatectomy Liver Failure (PLF)
A study testing Extracorporeal liver support therapy (ELS) in people with Post Hepatectomy Liver Failure, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Hepatectomy Liver Failure
- What is being tested?
- Extracorporeal liver support therapy (ELS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery Gastrocentrum Karolinska Univeristy Hospital
Stockholm, 14186
About this study
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 %).
Read more
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:
- 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
Read the detailed description
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)
- Conditions
- Post Hepatectomy Liver Failure
- Being tested
- Extracorporeal liver support therapy (ELS)
- Keywords
- Liver resection, post hepatectomy liver failure, liver dialysis, encephalopathy, mortality
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Postoperative Extracorporal Liver Support Therapy (ELS) | Experimental | Early Postoperative Extracorporal Liver Support Therapy (ELS) by using the Molecular Adsorbent Recirculating System (MARS) Receives: Device: Extracorporeal liver support therapy (ELS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: First two weeks postoperatively after major hepatectomy
Number of PLF patients who develop serious adverse events during ELS
At least five sessions of Mars. Westhaven (criteria 1-4)
Measured: First two weeks postoperatively after major hepatectomy
Secondary outcomes (4)
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)
Measured: First two weeks postoperatively after major hepatectomy
Portal flow (ml/minute) before and during ELS
At least five sessions of Mars
Measured: First two weeks postoperatively after major hepatectomy
To assess liver function by use of Indocyanine green clearance (ICG)(% clearance/unit time) under ELS treatment
At least five sessions of Mars
Measured: First two weeks postoperatively after major hepatectomy
Portal pressure (cmH2O) before and during ELS
At least five sessions of Mars
Measured: First two weeks postoperatively after major hepatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Hepatectomy Liver FailureStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
- Investigators
- Bengt Isaksson, Ass prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011424
- Sponsor's protocol ID
- 2013/149-31/2
- Status last verified
- Jan 2019
- First submitted
- 24 Oct 2016
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication in peer reviewed journal
Publications
Gilg S, Sparrelid E, Engstrand J, Baumgartner R, Nowak G, Stal P, D'Souza M, Jansson A, Isaksson B, Jonas E, Stromberg C. Molecular adsorbent recirculating system treatment in patients with post-hepatectomy liver failure: Long-term results of a pilot study. Scand J Surg. 2022 Sep;111(3):48-55. doi: 10.1177/14574969221112224. Epub 2022 Aug 24.
PubMed 36000747
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Extracorporal Liver Support Therapy (ELS) as a Tool to Manage Post Hepatectomy Liver Failure (PLF)
- ClinicalTrials.gov ID
- NCT03011424
- Acronym / sponsor ID
- 2013/149-31/2
- Conditions
- Post Hepatectomy Liver Failure
- Keywords
- Liver resection, post hepatectomy liver failure, liver dialysis, encephalopathy, mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early Postoperative Extracorporal Liver Support Therapy (ELS) | Experimental | Device: Extracorporeal liver support therapy (ELS)Early Postoperative Extracorporal Liver Support Therapy (ELS) by using the Molecular Adsorbent Recirculating System (MARS) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Early Postoperative Extracorporal Liver Support Therapy (ELS) |
Primary outcome
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).
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)
4 secondary outcomes
The predictive value of liver enzymes and bilirubin changes as marker of liver failure
Time frame: First two weeks postoperatively after major hepatectomy
Portal flow (ml/minute) before and during ELS
Time frame: First two weeks postoperatively after major hepatectomy
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
Portal pressure (cmH2O) before and during ELS
Time frame: First two weeks postoperatively after major hepatectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Derived from this study: PubMed 36000747Gilg S, Sparrelid E, Engstrand J, Baumgartner R, Nowak G, Stal P, D'Souza M, Jansson A, Isaksson B, Jonas E, Stromberg C. Molecular adsorbent recirculating system treatment in patients with post-hepatectomy liver failure: Long-term results of a pilot study. Scand J Surg. 2022 Sep;111(3):48-55. doi: 10.1177/14574969221112224. Epub 2022 Aug 24.
- Individual participant dataSharing planned: Yes. Publication in peer reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bengt Isaksson, Ass prof principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal liver support therapy (ELS) in people with Post Hepatectomy Liver Failure, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03011424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.