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

描述(由申请人提供)：我们建议扩大并维持成人对成人活体供肝移植队列研究数据协调中心(A2ALL DCC)，该中心将支持一个移植中心联盟在活体供肝移植(LDLT)方面进行持续的观察性和干预性研究，以促进对已捐献肝叶的活体个人以及那些接受和/或接受LDLT手术的活体个人进行移植的短期和长期医疗和健康相关生活质量结果的了解。此外，我们将通过对这一独特过程的研究，深入了解肝脏再生和其他生物学过程。拟议的DCC由最初的A2ALL DCC团队组成，该团队由活体器官捐赠者移植、肝病、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数据库链接的研究领域的协作专家组成。 数据中心将继续支持该项目，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门知识。DCC的具体科学目标将与A2ALL指导委员会合作制定。拟议的科学活动包括：1)确定LDLT供体的长期结果，包括与健康相关的生活质量，2)在LDLT环境中将免疫抑制降至最低的方案，3)继续关注丙型肝炎和肝细胞癌，4)确定最有利于LDLT的受体和供体特征，以及5)评估LDLT的新方法，以改善供体和受体的结果。 公共卫生相关性：社会和专业移植团体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A2ALL联盟成功实现其许多最初目标的基础上，关于LDLT的几个重要研究问题和临床问题仍然需要解决。在这些问题中，最重要的是决定活着的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受者术后并发症、资源利用、恢复时间和恢复足够的肝功能等短期问题。评估捐赠者的长期健康状况的关键是将其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也仍然存在重要问题：将免疫抑制降至最低的可能性、在特殊人群(例如，肝细胞癌和/或丙型肝炎病毒感染者)中使用LDLT移植物，以及研究特征以确定哪些受者使用LDLT移植物可能比DDLT移植物做得更好。本研究建议继续使用原工程中建造的结构来回答这些关键的研究问题。

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.