Living Donor Liver Transplantation Cohort Study

活体肝移植队列研究

• 批准号: 7498394
• 负责人: CARL L. BERG
• 金额: $ 17万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-17 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7498394
• 关键词: Acute Liver Failure; Adult; Allografting; Cessation of life; Child; Chronic; Chronic Hepatitis C; Clinical; Clinical Research; Clinical Research Protocols; Cohort Studies; Counseling; Data; Data Collection; Databases; Decision Analysis; Decision Making; Development; Dissection; Drug Formulations; Evaluation; Factor Analysis; Future; Healthcare Systems; Hepatitis C; Hepatitis C virus; Hepatocyte; Heterogeneity; Histologic; Human Resources; Infection; Injury; Institution; Kinetics; Lead; Liver; Liver diseases; Living Donor Liver Transplantation; Living Donors; Medical; Methods; Modeling; Molecular Virology; Natural regeneration; Numbers; Operative Surgical Procedures; Organ; Organ Donor; Outcome; Pathway interactions; Patients; Policies; Population; Procedures; Protocols documentation; Rate; Reporting; Research; Research Personnel; Research Proposals; Role; Serum; Societies; Staging; Standards of Weights and Measures; Techniques; Time; Transplant Recipients; Transplantation; United Network for Organ Sharing; United States; Universities; Viral; Virginia; cohort; cost; cost effectiveness; data modeling; liver transplantation; multidisciplinary; novel strategies; programs; prospective; receptor

DESCRIPTION (provided by applicant):As the disparity between number of potential liver transplant recipients and available cadaveric organs has widened, novel approaches have been developed to permit the successful transplantation of the largest possible number of patients with end-stage liver disease. The most promising of these strategies has involved the application of adult to adult living donor liver transplantation (LDLT). More than fifteen U.S. transplant centers have now utilized LDLT as a standard method for liver replacement. Despite the increasingly widespread application of this approach, considerable heterogeneity exists between centers regarding donor and recipient evaluation as well as the surgical techniques employed. Moreover, information is lacking regarding outcomes of this procedure for both donor and recipient, no data available to identify donors or recipients who may benefit most (or least) from this procedure, and no data to determine whether using LDLT is a cost-effective strategy. In this setting, we propose to participate as a transplant center (TC) in the LDLT Clinical Research Consortium. In this role, we propose to participate in the development of a prospective comprehensive data base and information core that will permit the dissection of the factors which lead to favorable, or unfavorable, outcomes in LDLT as compared to standard cadaveric transplantation. The existing UVA STRANDS database will permit retrospective collection of data from LDLT and cadaveric transplants performed over the last 5 years. In addition, the TC proposes to build on its institutional strengths to lead two clinical research protocols. The first protocol will develop a Cost Utility Decision Analysis using the Adult to Adult Living Donor Liver Transplantation Cohort. This research will yield a valid decision analysis model that can be used in a general patient population to better define subpopulations that would benefit from LDLT as opposed to cadaveric liver transplant. Costs and utilities to the health care system and the patients involved will be clarified for use in patient counseling, medical decision-making, and policy formulation. The second clinical research proposal will examine the outcomes of LDLT in patients infected with hepatitis C and compare these outcomes to cadaveric controls. Mechanisms that contribute to rapid allograft infection and injury will be examined including hepatocyte infection, rates of viral replication and kinetics of serum viral clearance.

描述（由申请人提供）：由于潜在的肝移植受体数量与可用的尸体器官之间的差异已经扩大，因此已经开发出了新的方法，以成功地移植最大数量的终末期肝病患者。这些策略中最有希望的是将成人生物供体肝移植（LDLT）应用于成人。现在，超过15个美国移植中心已将LDLT用作肝脏置换的标准方法。尽管这种方法越来越广泛地应用，但有关捐助者和接受者评估的中心之间仍然存在相当大的异质性以及所采用的手术技术。此外，对于捐助者和收件人，缺乏有关此程序结果的信息，没有可用的数据来识别可能从该程序中受益最多（或最少）的捐助者或接收者，也没有数据来确定使用LDLT是否是一种成本效益的策略。在这种情况下，我们建议在LDLT临床研究联盟中担任移植中心（TC）。在这一角色中，我们建议参与前瞻性全面数据库和信息核心的开发，该数据库将允许与标准的尸体移植相比，允许解剖LDLT中有利或不利的结果的因素。现有的UVA链数据库将允许回顾性收集LDLT和尸体移植物在过去5年中进行的。此外，TC建议以其机构优势建立领导两种临床研究方案。第一个方案将使用成人对成人供体肝移植队列的成年人进行成本公用事业决策分析。这项研究将产生一个有效的决策分析模型，该模型可用于普通患者人群，以更好地定义将受益于LDLT而不是尸体肝移植的亚群。医疗保健系统和涉及患者的成本和公用事业将被阐明用于患者咨询，医疗决策和政策制定。第二项临床研究建议将检查感染丙型肝炎的患者LDLT的结果，并将这些结果与尸体对照进行比较。将检查导致快速同种异体感染和损伤的机制，包括肝细胞感染，病毒复制率和血清病毒清除的动力学。