Early Postoperative Extracorporal Liver Support Therapy (ELS) as a Tool to Manage Post Hepatectomy Liver Failure (PLF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of PLF patients who develop serious adverse events during ELS according to SOFA scores and Westhaven criteria
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Early Postoperative Extracorporal Liver Support Therapy (ELS)
Early Postoperative Extracorporal Liver Support Therapy (ELS) by using the Molecular Adsorbent Recirculating System (MARS)
干预措施: Extracorporeal liver support therapy (ELS) (Device)
结局指标
主要结局
Number of PLF patients who develop serious adverse events during ELS according to SOFA scores and Westhaven criteria
时间窗: 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
时间窗: First two weeks postoperatively after major hepatectomy
At least five sessions of Mars. Westhaven (criteria 1-4)
次要结局
- To assess liver function by use of Indocyanine green clearance (ICG)(% clearance/unit time) under ELS treatment(First two weeks postoperatively after major hepatectomy)
- The predictive value of liver enzymes and bilirubin changes as marker of liver failure(First two weeks postoperatively after major hepatectomy)
- Portal pressure (cmH2O) before and during ELS(First two weeks postoperatively after major hepatectomy)
- Portal flow (ml/minute) before and during ELS(First two weeks postoperatively after major hepatectomy)
研究者
Lars Lundell
Professor
Karolinska University Hospital