Expanding Donor Pool for Live Donor Liver Transplantation: Utilization of Donors With NASH After Optimization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Effect of donor optimization protocol on body weight in donors with biopsy proven NASH
研究概览
简要总结
Live donor liver transplantation (LDLT) is the treatment of choice for end-stage liver disease, predominantly in the East, where deceased donor liver transplantation is sparse. In LDLT, donor selection has to be stringent; as the donor safety is thepriority. Live liver donors (LLD) with complex biliary and vascular anatomy are increasingly being accepted for donation with the betterment of technical expertise. One of the commonest reasons for LLD rejection is the hepatic parenchymal abnormality because ofsteatosis and steatohepatitis, which can increase the donor risk. Retrospective analysis of donors with non-alcoholic steatohepatitis(NASH) who were optimized and taken up for major hepatectomy from June 2011 to January 2018will be performed.
详细描述
Study Design Aim and Objective -
- Primary objective:
- To study the effect of donor optimization protocol in donors with biopsy proven NASH
- To study thebiochemical (LFTSs & INR) recovery in donors with NASH after major hepatectomy
- To compare their biochemical recovery parameters (LFTs & INR) with that of non NASH donors.
- Secondary objectives:
- To study incidence of NASH among live liver donors
- To study their respective recipients' outcomes
- To study the morbidity among LLDs with NASH after major hepatectomy
Methodology:
- Study population:Patients underwentLDLT from June 2011 to January 2019 at Institute of Liver & Biliary Sciences, New Delhi
- Study design:Retrospective study
- Study period:from June 2011 to January 2019
- Sample size with justification:All consecutive LLDs with at least one year of follow up post-operatively
- Intervention: none
- Monitoring and assessment:none Statistical Analysis:Categorical variables were presented as number (percentage) and were compared using the Chi-square test. Continuous variables were presented as mean (standard deviation, SD) and were compared using Mann-Whitney U Test.
Adverse Effects: None Stopping Rule of Study: None
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Live Liver Donors who had undergone major hepatectomy (removal of ≥ 3 liver segments)
排除标准
- •Live Liver Donors who had undergone minor hepatectomy (removal of < 3 liver segments)
- •Live Liver Donors of recipients with acute liver failure.
结局指标
主要结局
Effect of donor optimization protocol on body weight in donors with biopsy proven NASH
时间窗: 6 weeks to 3 months
Effect of donor optimization protocol on liver attenuation index in donor with biopsy proven NASH.
时间窗: 6 weeks to 3 months
Effect of donor optimization protocol on lipid profile in donors with biopsy proven NASH.
时间窗: 6 weeks to 3 months
Effect of donor optimization protocol on Liver Function Test in donors with biopsy proven NASH.
时间窗: 6 weeks to 3 months
Improvement in Liver Function Test in donors with NASH after major hepatectomy.
时间窗: Day 0 to Day 7
Improvement in Coagulation Profile in donors with NASH after major hepatectomy.
时间窗: Day 0 to Day 7
Improvement in Liver Function Test between both the groups
时间窗: Day 0 to Day 7
次要结局
- Morbidity among Live Liver Donors with NASH after major hepatectomy(Day 0 to Day 30)
- Post Operative complications of recipients in both the groups(Day 0 to day 30)
- Proportion of NASH among live liver donors(Day 0)