Adult to Adult Living Donor Liver Transplantation

成人对成人活体供肝移植

• 批准号: 7120584
• 负责人: ROBERT A FISHER
• 金额: $ 26.79万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 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 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7120584
• 关键词: adult human (21+); biopsy; clinical research; cooperative study; epidemiology; hepatectomy; human morbidity; human mortality; human subject; liver transplantation; longitudinal human study; medical complication; patient oriented research; quality of life; tissue donors

DESCRIPTION (provided by applicant):Over the past decade a growing shortage of donated organs has greatly increased the number of patients who have developed complications of end-stage cirrhosis including hepatocellular carcinoma (HCC) and the mortality for patients awaiting liver transplantation (LT). Living donor liver transplantation (LDLT) was conceived as a way to increase the availability of donated organs and was initiated in infants and children more than a decade ago. Controlled trials demonstrated the safety and efficacy of this procedure. Recently, LDLT has been adapted for the adult. Since then patients, their families and the transplant community have embraced this procedure despite reports of donor morbidity, mortality and early reports that recipients may have increased post-operative complications and reduced survival compared to CADLT. The specific aims of the LDLT cohort study is to define the short and long term risks of morbidity and mortality for the adult donor and to determine the efficacy of this procedure for the adult recipient compared to patients undergoing LT with a cadaveric liver (CADLT). Individuals interested in becoming living donors will be asked to participate in this study. Those who are selected and undergo the surgical procedure will be followed at periodic intervals to define the long term morbidity and mortality of the procedure. Individuals not selected as living donors will be matched to the actual donors 2:1 by age, race and gender and also followed prospectively as a donor control group. Individuals being evaluated for LT will be asked if they would be interested in undergoing LDLT. Those patients who identify an acceptable donor and undergo LDLT will be followed prospectively at periodic intervals to define the short and long term morbidity and mortality associated with this procedure. Those patients who are unable to identify a living donor will be matched to an actual LDLT recipient 2:1 by age, race, gender, disease etiology and severity of liver disease (MELD score). These patients will act as the recipient control group and will and be followed prospectively before and after they undergo CADLT. Ancillary studies accompanying the main trial will specifically evaluate the ability of LDLT to improve the long term outcome of patients with HCC and to evaluate the effects of donation and LDLT on hepatic histology.

描述（由申请人提供）：在过去的十年中，捐赠器官的越来越短，大大增加了患有终末期肝硬化并发症的患者数量，包括肝细胞癌（HCC）和等待肝移植（LT）的患者的死亡率。活着的供体肝移植（LDLT）被认为是增加捐赠器官的可用性的一种方式，并在十多年前在婴儿和儿童中启动。对照试验证明了此程序的安全性和功效。最近，LDLT已适用于成年人。从那时起，尽管有报道称供体发病率，死亡率和早期报道，但与CADLT相比，患者，家人和移植社区已经接受了这种程序。 LDLT队列研究的具体目的是与患有尸体肝LT的患者（CADLT）相比，定义了成年捐助者的短期和长期发病风险和长期死亡风险，并确定该程序对成人接受者的疗效。有兴趣成为活捐助者的人将被要求参加这项研究。被选中并接受外科手术的人将定期遵循，以定义该程序的长期发病率和死亡率。没有被选为活捐赠者的个人将与实际的捐助者2：1按年龄，种族和性别相匹配，并前瞻性地成为捐助者对照组。将询问对LT进行评估的个人是否有兴趣接受LDLT。那些确定可接受的供体并接受LDLT的患者将被预期遵循，以定期定义与此程序相关的短期和长期发病率和死亡率。那些无法识别活捐赠者的患者将与实际的LDLT接受者相匹配2：1，年龄，种族，性别，疾病病因和肝病的严重程度（MELD评分）。这些患者将充当接受者对照组，并将在接受CADLT之前和之后进行前瞻性遵循。伴随主要试验的辅助研究将专门评估LDLT改善HCC患者长期结局的能力，并评估捐赠和LDLT对肝组织学的影响。