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临床试验/NCT02659553
NCT02659553已完成不适用

Impact of Graft Steatosis on Post-operative Complications After Liver Transplantation

Sohag University1 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
271
试验地点
1
主要终点
Post-operative complications rate

研究概览

简要总结

  1. Clinical impact of graft steatosis on postoperative complications after OLT.
  2. Recommendations to improve outcomes after transplantation of steatotic livers and increase donor pool.

详细描述

Introduction Solid organ transplantation has become the standard of care for selected patients with end-stage organ dysfunction. With improved surgical techniques, more effective immunosuppressive therapies, and better anti-infective medications, outcomes after solid organ transplantation have improved over the last several years.

The excellent survival rates reported after orthotopic liver transplantation (OLT) have increased the demand for liver transplants and have enhanced the disparity between the number of available donor organs and the need for such organs.

The lack of available organs for liver transplantation (LT) associated with the increased death rates among patients on most waiting lists for LT has triggered the use of so-called extended criteria donor (ECD) grafts, previously called ''suboptimal grafts''. Among the wide range of these ECD livers, hepatic steatosis is one of the most frequent disorders, which is mostly related to an increasing prevalence of non-alcoholic fatty liver disease (NAFLD).

Non-alcoholic fatty liver disease (NAFLD) is increasingly significant in healthy individuals for its high worldwide prevalence, an association with the metabolic syndrome such as insulin resistance, diabetes, dyslipidemia and obesity, and an association with liver-related morbidity and mortality.

Clinical evaluation and current imaging modalities, and serological and laboratory tests can be strongly suggestive of the presence of hepatic steatosis, but none of these is capable of distinguishing steatohepatitis (SH) from uncomplicated steatosis; likewise, these evaluations can generally detect advanced liver disease (e.g. portal hypertension), but none can truly assess the degree of liver necroinflammatory injury, lesser stages of fibrosis and architectural remodeling. Liver biopsy evaluation, therefore, remains the 'gold standard' to unequivocally diagnose SH and to document the severity of hepatic injury and fibrosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

入选标准

  • All adult patients candidates for liver transplantation are included in this study

排除标准

  • Pediatric patients are excluded.
  • Re- transplanted patients.
  • cases with no histopathological examination records

结局指标

主要结局

Post-operative complications rate

时间窗: through study completion, an average of 1 year

according to the Clavien- Dindo classification system

次要结局

  • Biliary complications: stricture or leakage(through study completion, an average of 1 year)
  • early graft dysfunction (EGD), which is defined as impaired initial allograft function with high peak serum transaminase and persistent high bilirubin levels.(through study completion, an average of 1 year)
  • Primary graft non-function (PNF), which is defined as primary failure of the graft followed by death or re-transplantation within the first post transplantation week.(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emad Ali Ahmed Ali

Principal Investigator

Sohag University

研究点 (1)

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