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出现肝细胞癌（HCC）等终末期肝硬化并发症的患者数量以及等待肝移植（LT）患者的死亡率。活体肝移植（LDLT）被认为是增加捐赠器官可用性的一种方式，十多年前在婴儿和儿童中开始实施。对照试验证明了该程序的安全性和有效性。最近，LDLT 已适用于成人。从那时起，患者、他们的家人和移植界都接受了这种手术，尽管有报道称与 CADLT 相比，捐赠者发病率、死亡率较高，而且早期报道称受者可能会增加术后并发症并降低生存率。 LDLT 队列研究的具体目的是确定成人捐献者发病和死亡的短期和长期风险，并确定与接受尸体肝脏 LT (CADLT) 的患者相比，该手术对成人受者的疗效。有兴趣成为活体捐赠者的个人将被要求参加这项研究。那些被选中并接受外科手术的人将定期进行随访，以确定手术的长期发病率和死亡率。未选为活体捐赠者的个人将按年龄、种族和性别与实际捐赠者进行 2:1 匹配，并作为捐赠者对照组进行前瞻性跟踪。接受 LT 评估的个人将被询问是否有兴趣接受 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。那些无法确定活体捐献者的患者将根据年龄、种族、性别、疾病病因和肝病严重程度（MELD 评分）以 2:1 的比例与实际的 LDLT 接受者进行匹配。这些患者将作为接受者对照组，并将在接受 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 对肝组织学的影响。