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.

该提案的总体目的是建立一个临床研究财团来定义ALDLT的结果。 我们提出以下具体旨在充分评估ALDLT的影响： 1。核心研究：为成人LDLT和非ALDLT患者建立供体和受体核心信息数据库 假设：ALDLT短期生存结果，但不是并发症率，相当于整个尸体和SLT 移植。我们和其他人在ALDLT中取得了出色的短期生存成果，尽管受体率很高 并发症，非紧急患者。为了充分评估ALDLT的好处，该技术将应用于紧急 和非紧急接收者，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接收者以及C）最终没有接受移植的候选人。活着的捐助者 节将比较不接受捐款的捐助者和潜在的捐助者。主要终点定义生存 移植后1、2和3年的捐赠者和接受者的结果和并发症率。这将阐明 与整个尸体，SLT和对照（未转移）患者相比，ALDLT的功效 接受者的状态，并确定与未移植非植物的自然历史相比，ALDLT是否合理 紧急控制。次要终点评估技术变化对术后恢复，肝脏的影响 再生后的再生，生活捐赠对尸体供体池的影响，并定义了捐助者排除标准。 2。接受者结果的临床研究方案：确定ALDLT对移植后HCV复发的影响 在移植接受者假设中：ALDLT可能伴随着HCV与整个的加速复发 尸体肝移植。在我们的中心，在ALDLT受体中观察到快速和严重的HCV复发。 对于整个器官移植患者，可以抵消活捐赠者早期移植的好处。这个协议 将6个月，1、2和3 移植后年。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 我们的次要终点研究了疾病和HCV RNA水平。 3。供体结果的临床研究方案：确定与健康相关的生活质量和资源 成人生活捐赠假设的利用：在短期和 ALDLT后，ALDLT接收者的HRQL可能会增强。将比较捐助者和接受者的HRQL 通过通用和疾病特异性仪器进行移植后6和12个月之前，在ALDLT之前和12个月之前。此外， 将进行卫生公用事业指数评估和卫生保健资源利用率的评估。