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（申请人提供）：在过去的十年中，捐赠器官的日益短缺大大增加了终末期肝硬化（包括肝细胞癌（HCC））并发症的患者数量和等待肝移植（LT）患者的死亡率。活体供肝移植（LDLT）被认为是一种增加捐赠器官可用性的方法，十多年前开始在婴儿和儿童中进行。对照试验证明了该方法的安全性和有效性。最近，LDLT已适用于成人。从那时起，尽管有供体发病率和死亡率的报告，以及早期报告称与CADLT相比，受者可能增加术后并发症和降低生存率，但患者、他们的家人和移植社区已经接受了这种手术。LDLT队列研究的具体目的是确定成年供体发病率和死亡率的短期和长期风险，并确定该手术对成年受体的疗效，与接受尸体肝移植（CADLT）的患者进行比较。有兴趣成为活体捐献者的个人将被邀请参加这项研究。那些被选中并接受手术的人将定期随访，以确定手术的长期发病率和死亡率。未被选为活体供体的个体将按年龄、种族和性别按2:1匹配实际供体，并作为供体对照组进行前瞻性随访。接受肝移植评估的个人将被问及他们是否有兴趣接受肝移植。那些确定了可接受供体并接受LDLT的患者将定期进行前瞻性随访，以确定与该手术相关的短期和长期发病率和死亡率。那些无法确定活体供体的患者将按照年龄、种族、性别、疾病病因和肝病严重程度（MELD评分）按2:1匹配实际的LDLT受体。这些患者将作为受体对照组，在接受CADLT之前和之后进行前瞻性随访。伴随主要试验的辅助研究将专门评估LDLT改善HCC患者长期预后的能力，并评估捐赠和LDLT对肝脏组织学的影响。