Adult-to-Adult Living Donor Liver Transplantation Study Data Coordinating Center

描述（申请人提供）：我们建议扩大和维持成人间活体肝移植队列研究数据协调中心（A2 ALL DCC），将支持移植中心联盟在活体肝移植（LDLT）中进行持续的观察和干预研究，以促进对短期和长期医疗和健康的理解-移植对已捐献肝叶的活体个体以及LDLT程序的候选者和/或接受者的相关生活质量结果。此外，我们将通过研究这种独特的程序来深入了解肝脏再生和其他生物过程。拟议的DCC由原A2 ALL DCC团队组成，该团队由活体器官供体移植、肝病学、临床研究设计、数据库管理以及涉及大型公共和私人电子医疗保健数据库链接的研究领域的合作专家组成。 DCC将继续支持该项目，包括研究协调、通信和后勤、研究设计、集中数据管理和分析专业知识。DCC的具体科学目标将与A2 ALL指导委员会合作制定。拟议的科学活动包括：1）确定长期LDLT供体结果，包括健康相关的生活质量，2）LDLT环境中免疫抑制最小化的方案，3）继续关注丙型肝炎和肝细胞癌，4）识别最有利于LDLT的受体和供体特征，5）评价LDLT的新方法以改善供体和受体的结果。 公共卫生相关性：社会和专业移植界有义务向过去和未来的活体器官捐赠者及其接受者学习他们的经验。在A2 ALL联盟成功实现其许多原始目标的基础上，关于LDLT的几个重要研究问题和临床问题仍然需要解决。这些问题中最重要的是确定活体肝脏捐赠者的长期健康和福祉。对LDLT安全性的理解必须超越供体和受体术后并发症、资源利用、恢复时间和充分肝功能恢复等短期问题。评估捐献者长期健康状况的关键是与没有捐献的具有相似特征的人进行比较。在潜在受体中使用LDLT也存在重要问题：免疫抑制最小化的可能性，在特殊人群中使用LDLT移植物（例如肝细胞癌和/或丙型肝炎病毒感染的人），以及研究特征以确定LDLT移植物可能比DDLT移植物更好的受体。本研究建议继续使用原项目中构建的结构来回答这些关键研究问题。

DESCRIPTION (provided by applicant): We propose to expand and maintain the Adult to Adult Living Donor Liver Transplantation Cohort Study Data Coordinating Center (A2ALL DCC) that will support a consortium of transplant centers in conducting continued observational and interventional research in living donor liver transplantation (LDLT) so as to facilitate understanding of the short and long-term medical and health-related quality of life outcomes of transplantation on living individuals who have donated a liver lobe as well as those who are candidates for and/or recipients of LDLT procedures. In addition, we will gain insight into liver regeneration and other biological processes through study of this unique procedure. The proposed DCC consists of the original A2ALL DCC team of collaborating experts in the fields of live organ donor transplantation, hepatology, clinical research design, database management, and research involving linkages of large public and private electronic health care databases. The DCC will continue to support the project, including research coordination, communications and logistics, study design, centralized data management, and analytical expertise. The specific scientific aims of the DCC will be developed in collaboration with the A2ALL Steering Committee. Proposed scientific activities include: 1) determination of long-term LDLT donor outcomes, including health-related quality of life, 2) protocols for immunosuppression minimization in the LDLT setting, 3) continued focus on hepatitis C and hepatocellular carcinoma, 4) identification of recipient and donor characteristics that are most favorable for LDLT, and 5) evaluation of newer approaches to LDLT to improve donor and recipient outcomes. PUBLIC HEALTH RELEVANCE: Society and the professional transplant community are obligated to past and future live organ donors and their recipients to learn from their experiences. Building on the success of the A2ALL consortium in achieving many of its original goals, several important research issues and clinical questions regarding LDLT still need to be addressed. Foremost among these issues is determining the long-term health and well-being of living liver donors. Understanding of the safety of LDLT must extend beyond short-term issues of post-operative complications of donors and recipients, resource utilization, recovery time, and restoration of adequate liver function. Critical to assessment of the long-term health of donors is comparison to persons with similar characteristics who did not donate. Important questions also remain regarding the use of LDLT in potential recipients: the possibility of immunosuppression minimization, use of LDLT grafts in special populations (e.g. persons with hepatocellular carcinoma and/or hepatitis C virus infection), and studying characteristics to identify those recipients who might do better with an LDLT graft than a DDLT graft. This study proposes to continue to use the structure built in the original project to answer these, key research questions.