ADLDT: An Opportunity to Expand the National Donor Pool

ADLDT：扩大国家捐助库的机会

• 批准号: 6660317
• 负责人: Rafik MARK GHOBRIAL
• 金额: $ 21.04万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 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/6660317
• 关键词: adult human (21+); clinical research; cooperative study; epidemiology; hepatitis C virus; human middle age (35-64); human subject; information systems; liver regeneration; liver transplantation; longitudinal human study; outcomes research; patient oriented research; postoperative complications; postoperative state; questionnaires; tissue donors

DESCRIPTION (provided by applicant):The overall objective of this proposal is to establish a Clinical Research Consortium to define the outcomes of ALDLT. We propose the following specific aims to fully evaluate the impact of ALDLT: 1. Core Study: Establish a Donor and Recipient Core Information Database for Adult LDLT and Non-ALDLT Patients Hypothesis: ALDLT short-term survival outcomes, but not complication rates, are equivalent to whole cadaveric and SLT transplantation. We and others, achieved excellent short-tem survival outcomes of ALDLT, despite a high rate of recipient complications, in non-urgent patients. To fully evaluate the benefits of ALDLT, the technique will be applied to both urgent and non-urgent recipients, and compare its outcomes to three sets of patient cohorts that include: a) whole organ recipients, b) cadaveric SLT recipients, and c) candidates who ultimately do not receive a transplant. The living donor section will compare living donors and potential donors who do not undergo donation. Primary endpoints define survival outcomes and complication rates in donors and recipients at 1, 2 and 3 years posttransplantation. This will elucidate the efficacy of ALDLT as compared to whole cadaveric, SLT, and control (untransplanted) patients in the entire spectrum of recipients' status, and determine if ALDLT is justified when compared to the natural history of non-transplanted non-urgent controls. Secondary endpoints assess the impact of technical variations on postoperative recovery, liver regeneration postdonation, impact of living donation on the cadaveric donor pool, and defines donor exclusion criteria.2. Clinical Research Protocol for Recipient Outcome: Determine the impact of ALDLT on Posttransplant HCV Recurrence in Transplant Recipients Hypothesis: ALDLT may be accompanied by accelerated recurrence of HCV versus whole cadaveric liver transplantation. Rapid and severe HCV recurrence observed, at our center, in ALDLT recipients compared to whole organ transplant patients, may offset the benefits of early transplantation with living donors. This protocol compares the time to histological recurrence of HCV in ALDLT and whole organ graft recipients at 6 months, 1, 2, and 3 years posttransplantation. The effects on patient and graft survival and the correlation between the degree of histological disease and HCV RNA levels are investigated by our secondary endpoints.3. Clinical Research Protocol for Donor Outcome: Determine Health-Related Quality of Life Outcomes and Resource Utilization of Adult Living Donation Hypothesis: HRQL of living donors is impacted in the short-, but not, the long-term and the HRQL of ALDLT recipients may be enhanced following ALDLT. HRQL in both donors and recipients will be compared before ALDLT and at 6 and 12 months posttransplantation through generic and disease-specific instruments. Additionally, health utility index assessments and evaluation of health care resource utilization will be conducted.

描述（由申请人提供）：该提案的总体目标是建立一个临床研究联盟来定义 ALDLT 的结果。我们提出以下具体目标来全面评估 ALDLT 的影响： 1. 核心研究：建立成人 LDLT 和非 ALDLT 患者的供者和受者核心信息数据库 假设：ALDLT 短期生存结果（而非并发症发生率）是重要的相当于全尸移植和SLT移植。尽管接受者并发症发生率很高，但我们和其他人在非紧急患者中取得了出色的 ALDLT 短期生存结果。为了充分评估 ALDLT 的益处，该技术将应用于紧急和非紧急受者，并将其结果与三组患者队列进行比较，包括：a) 全器官受者，b) 尸体 SLT 受者，c)最终没有接受移植的候选人。活体捐赠者部分将比较活体捐赠者和未接受捐赠的潜在捐赠者。主要终点定义了移植后 1、2 和 3 年捐赠者和接受者的生存结果和并发症发生率。这将阐明 ALDLT 与整个尸体、SLT 和对照（未移植）患者在整个受者状态范围内的疗效，并确定 ALDLT 与非移植非紧急对照的自然史相比是否合理。次要终点评估技术变化对术后恢复、捐献后肝再生的影响、活体捐献对尸体捐献者库的影响，并定义捐献者排除标准。2．受者结果的临床研究方案：确定 ALDLT 对移植受者移植后 HCV 复发的影响 假设：与整个尸体肝移植相比，ALDLT 可能伴随着 HCV 复发加速。在我们的中心，与全器官移植患者相比，在 ALDLT 接受者中观察到的快速且严重的 HCV 复发可能会抵消活体捐献者早期移植的益处。该方案比较了 ALDLT 和全器官移植受者在移植后 6 个月、1、2 和 3 年时 HCV 组织学复发的时间。我们的次要终点研究了对患者和移植物存活的影响以及组织学疾病程度和 HCV RNA 水平之间的相关性。3。捐赠者结果的临床研究方案：确定成人活体捐赠的与健康相关的生活质量结果和资源利用 假设：活体捐赠者的 HRQL 会受到短期影响，但不会受到长期影响，ALDLT 接受者的 HRQL 可能会受到影响ALDLT 后增强。将通过通用和疾病特异性仪器在 ALDLT 之前以及移植后 6 个月和 12 个月时比较捐赠者和接受者的 HRQL。此外，还将进行健康效用指数评估和医疗资源利用评价。