Right Lobe Living Donor Liver Transplantation in Adults

描述（由申请人提供）：位于查佩尔山的北卡罗来纳州大学（UNC-CH）的肝移植项目是一个完善且至关重要的区域资源。本申请提出了一项多中心合作核心研究，其中将对UNC-CH和其他移植中心（TC）的明确队列进行前瞻性随访，以提供关于活体供体和尸体肝移植的成人供体和受体结局的可靠、完整和可推广的信息。提出了一个数据库结构和信息核心，并讨论了每个建议的数据元素的相关性。这项核心研究将通过分析我们的历史队列来增强，现有的结果数据可以在参与临床研究联盟的所有移植中心（TC）中汇总。除了这些研究之外，本申请还提出了两种通用协议。第一项将深入研究活体捐赠者的短期和长期发病率和生活质量。第二部分将研究活体肝移植和尸体肝移植受者之间药物代谢和免疫抑制方案的差异。UNC-CH是临床研究联盟内的移植中心（TC），在过去18个月内进行了13次LDLT，总共进行了21次LDLT。UNC-CH的预测是每年50-60例CADLT和15-20例LDLT，因此允许招募和随访足够数量的患者参与联盟研究。CADLT和LDLT的患者和移植物总的一年存活率分别为90-95%和77-85%。UNC-CH的基础设施包括4名移植外科医生、5名肝病学家以及血管外科、麻醉学、放射学和血管/介入放射学、免疫学、传染病、肺病、病理学、药学、护理、血库、精神病学或心理学和社会服务领域的其他相关专业人员。所有研究都受益于使用Verne Caviness一般临床研究中心（GCRC）作为主要研究中心，并与胃肠道生物学和疾病中心（CGIBD）合作。与这一应用特别相关的是全球癌症研究中心的信息学服务和国际生物医学合作小组的流行病学服务。作为一个移植中心，联合国中心-CH致力于密切合作，包括成为指导委员会的成员。UNC-CH参与了多个多中心试验，并在与数据协调中心合作方面拥有丰富的经验基础。我们的应用程序对作为TC参与的强大机构支持包括接受共同协议的每位患者资助机制。

DESCRIPTION (provided by applicant):The Liver Transplant Program at the University of North Carolina at Chapel Hill (UNC-CH) is a well-established and vitally important regional resource. This application proposes a multi-center cooperative core study in which a well-defined cohort from UNC-CH and other Transplant Centers (TC) will be followed prospectively to provide reliable, complete, and generalizable information on adult donor and recipient outcomes for both living donor and cadaveric liver transplants. A database structure and information core is proposed, and this application discusses the relevance of each proposed data element. This core study will be augmented by analysis of our historical cohort for which existing outcome data can be pooled across all the Transplant Centers (TC) participating in the Clinical Research Consortium. In addition to these studies, this application proposes two common protocols. The first will examine in-depth the short and long-term morbidity and quality of life of living donors. The second will examine differences in drug metabolism and immunosuppressive regimen between recipients of living donor and cadaveric liver transplants. UNC-CH is well qualified to be a Transplant Center (TC) within the Clinical Research Consortium having performed 13 LDLT in the last 18 months and 21 LDLT total. Projections for UNC-CH are 50-60 CADLT and 15-20 LDLT per year, thereby allowing accrual and followup of more than sufficient numbers of patients to contribute to the Consortium studies. Overall one-year patient and graft survival for both CADLT and LDLT are 90-95% and 77-85% respectively. The UNC-CH infrastructure includes 4 transplant surgeons, 5 hepatologists, and other relevant professionals in vascular surgery, anesthesiology, radiology and vascular/interventional radiology, immunology, infectious disease, pulmonary disease, pathology, pharmacy, nursing, blood bank, psychiatry or psychology and social services. All studies benefit from use of the Verne Caviness General Clinical Research Center (GCRC) as a primary site and collaboration with the Center for Gastrointestinal Biology and Disease (CGIBD). Particularly relevant to this application are the GCRC's Informatics Services and the epidemiologic services of the CGIBD.As a Transplant Center, UNC-CH is committed to close collaborations including membership on the Steering Committee. UNC-CH has participated in multiple multi-center trials and has a rich experiential base in working with data coordinating centers. Our application's strong institutional support for participation as a TC includes acceptance of per patient funding mechanisms for the common protocols.