Right Lobe Living Donor Liver Transplantation in Adults

成人右叶活体肝移植

• 批准号: 8024730
• 负责人: Paul Hideyo Hayashi
• 金额: $ 0.74万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-02-24 至 2011-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8024730
• 关键词: Adult; Anesthesiology; Biology; Blood Banks; Blood Vessels; Body Weight; Caring; Clinical; Clinical Research; Clinical Trials Design; Cohort Studies; Collaborations; Commit; Cytochrome P450; Data; Data Coordinating Center; Data Element; Data Quality; Data Sources; Databases; Deterioration; Disease; Elements; Eligibility Determination; Enzymes; Epidemiology; Funding; Funding Mechanisms; Graft Survival; Immunosuppressive Agents; Infectious Disease Immunology; Informatics; Interventional radiology; Liver; Liver Regeneration; Living Donor Liver Transplantation; Living Donors; Lobe; Lung diseases; Measurement; Mental Health; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; North Carolina; Nurses; Observational Study; Operative Surgical Procedures; Outcome; Pathology; Patients; Pharmacy facility; Process; Protocols documentation; Psychiatry; Psychology; Qualifying; Quality of life; Radiology Specialty; Recording of previous events; Recovery; Regimen; Research Infrastructure; Research Personnel; Resources; Risk; Screening procedure; Services; Site; Social Work; Specific qualifier value; Staging; Transplant Recipients; Transplant Surgeon; Transplantation; Universities; Waiting Lists; Work; base; cohort; computerized; cytokine; database structure; design; drug metabolism; follow-up; functional status; gastrointestinal; improved; liver transplantation; mortality; multidisciplinary; prevent; programs; prospective; research study; satisfaction

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.

描述（由申请人提供）：北卡罗来纳大学教堂山分校（UNC-CH）的肝脏移植项目是一个建立良好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，在该研究中，来自UNC-CH和其他移植中心（TC）的定义明确的队列将被前瞻性地跟踪，以提供关于活体供体和尸体肝脏移植的成人供体和受体结果的可靠、完整和可概括的信息。提出了一个数据库结构和信息核心，该应用程序讨论了每个提出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汇集到所有参与临床研究联盟的移植中心（TC）。除了这些研究之外，本应用程序还提出了两个通用协议。第一个项目将深入研究活体捐献者的短期和长期发病率和生活质量。第二项研究将检查活体供体和尸体肝移植接受者在药物代谢和免疫抑制方案方面的差异。UNC-CH有资格成为临床研究联盟内的移植中心（TC），在过去的18个月里进行了13例LDLT手术，总计21例。UNC-CH的预测是每年50-60例CADLT和15-20例LDLT，因此允许累积和随访的患者数量超过足够的数量，为联盟研究做出贡献。CADLT和LDLT患者和移植物的1年总体生存率分别为90-95%和77-85%。UNC-CH的基础设施包括4名移植外科医生、5名肝病专家，以及其他相关专业人员，包括血管外科、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。凡尔纳腔内普通临床研究中心（GCRC）作为主要研究地点，并与胃肠道生物学和疾病中心（CGIBD）合作，所有研究都受益。与此应用特别相关的是GCRC的信息学服务和CGIBD的流行病学服务。作为一个移植中心，北卡罗来纳大学附属医院致力于密切合作，包括成为指导委员会的成员。UNC-CH参与了多个多中心试验，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参与的强有力的机构支持包括接受每个患者的共同协议资助机制。