Adult to Adult Living Donor Liver Transplantation

成人对成人活体供肝移植

• 批准号: 6945838
• 负责人: ROBERT A FISHER
• 金额: $ 32.75万
• 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/6945838
• 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）：在过去十年中，捐献器官的日益短缺大大增加了患有终末期肝硬化并发症（包括肝细胞癌（HCC））的患者数量，并增加了等待肝移植（LT）患者的死亡率。活体肝移植（LDLT）被认为是一种增加捐赠器官可用性的方法，十多年前在婴儿和儿童中开始。对照试验证明了该手术的安全性和有效性。最近，LDLT已适用于成人。从那时起，患者，他们的家人和移植社区已经接受了这一程序，尽管有供体发病率，死亡率和早期报告称，与CADLT相比，受体可能会增加术后并发症和降低生存率。LDLT队列研究的具体目的是确定成人供体的短期和长期发病率和死亡率风险，并确定与接受尸体肝LT（CADLT）的患者相比，该手术对成人受体的疗效。将邀请有兴趣成为活体供体的个人参加本研究。将定期随访入选并接受外科手术的患者，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、种族和性别与实际供体2：1匹配，并作为供体对照组进行前瞻性随访。将询问接受LT评估的个人是否有兴趣接受LDLT。将定期前瞻性随访确定可接受供体并接受LDLT的患者，以确定与该手术相关的短期和长期发病率和死亡率。无法识别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）与实际LDLT接受者2：1匹配。这些患者将作为受体对照组，并将在接受CADLT前后进行前瞻性随访。伴随主试验的辅助研究将专门评价LDLT改善HCC患者长期结局的能力，并评价捐献和LDLT对肝组织学的影响。