ADLDT: An Opportunity to Expand the National Donor Pool

ADLDT：扩大国家捐助者库的机会

• 批准号: 7617327
• 负责人: Rafik MARK GHOBRIAL
• 金额: $ 7.21万
• 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/7617327
• 关键词: Abbreviations; Address; Adult; Chronic; Clinical Research; Clinical Research Protocols; Complication; Databases; Disease; Donor Exclusions; End Point; Enrollment; Ethnic Origin; Evaluation; Exclusion Criteria; Generic Drugs; Graft Survival; Health; Healthcare; Hepatitis C virus; Intervention; Life; Liver; Liver Regeneration; Liver diseases; Living Donor Liver Transplantation; Living Donors; Measurement; Modeling; Natural History; Numbers; Organ; Organ Transplantation; Outcome; Participant; Patients; Postoperative Period; Protocols documentation; Quality of life; Questionnaires; RNA; Rate; Recovery; Recurrence; Resources; Sample Size; Score; Severity of illness; Staging; Survival Analysis; Techniques; Tern; Time; Transplant Recipients; Transplantation; United Network for Organ Sharing; Upper arm; Variant; Viral; base; cohort; health care service utilization; health related quality of life; indexing; instrument; liver transplantation; programs

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-tern 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.

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患者的供体和受体核心信息数据库 假设：ALDLT 的短期生存结果（但不是并发症发生率）与整个尸体和 SLT 相当 移植。尽管接受者率很高，但我们和其他人在 ALDLT 中取得了出色的短期生存结果 非紧急患者的并发症。为了充分评估 ALDLT 的益处，该技术将应用于紧急情况 和非紧急接受者，并将其结果与三组患者队列进行比较，其中包括：a) 整个器官 接受者，b) 尸体 SLT 接受者，以及 c) 最终未接受移植的候选人。活体捐赠者 该部分将比较活体捐赠者和未接受捐赠的潜在捐赠者。主要终点定义生存率 移植后 1、2 和 3 年捐赠者和接受者的结果和并发症发生率。这将阐明 与整个尸体、SLT 和对照（未移植）患者相比，ALDLT 在整个范围内的疗效 接受者的状况，并确定与非移植非接受者的自然史相比，ALDLT 是否合理。 紧急控制。次要终点评估技术变化对术后恢复、肝功能的影响 捐赠后再生、活体捐赠对尸体捐赠者库的影响，并定义捐赠者排除标准。 2. 受者结果的临床研究方案：确定 ALDLT 对移植后 HCV 复发的影响 移植受者假说：与整体肝移植相比，ALDLT 可能伴随着 HCV 加速复发 尸体肝移植。在我们中心观察到的 ALDLT 接受者中 HCV 快速且严重复发的情况与 对于整个器官移植患者来说，可能会抵消早期活体捐献者移植的好处。本协议 比较了 ALDLT 和全器官移植受者在 6 个月、1、2 和 3 个月时 HCV 组织学复发的时间 移植后数年。对患者和移植物存活的影响以及组织学程度之间的相关性 疾病和 HCV RNA 水平通过我们的次要终点进行调查。 3. 捐赠者结果的临床研究方案：确定与健康相关的生活质量结果和资源 成人活体捐赠假说的利用：活体捐赠者的 HRQL 会受到短期影响，但不会受到长期和长期影响。 ALDLT 接受者的 HRQL 在 ALDLT 后可能会得到增强。将比较捐赠者和接受者的 HRQL 在 ALDLT 之前以及移植后 6 个月和 12 个月时，通过通用和疾病特异性仪器进行检测。此外， 开展健康效用指数评估和医疗资源利用评价。