Outcomes of Liver Transplantation in Low Weight Children After Reducing the Lateral Segment of a Living Donor, Adapting the Shape and Size of the Graft to the Needs of the Recipient
2018年7月19日 更新者：MICAELA RAICES、Hospital Italiano de Buenos Aires
Short and Long-term Outcomes After Transplantation With Hyper-reduced Liver Grafts in Low-Weight Pediatric Recipients
The shortage of organs has always been a problem in pediatric liver transplants due to the lack of donors with an adequate size.
Different techniques of hepatic reduction have been described that allow to use larger organs in the pediatric population.
However, in these techniques the maximum reduction achieved by segments 2 and 3 is excessive for low-weight children.
Since 1997 the liver transplantation group at Hospital Italiano de Buenos Aires has developed and practiced a technique called hepatic hyper-reduction, which consists in reducing the lateral segment of a living donor, adapting the shape and size of the graft to the needs of the recipient.
The investigators have performed approximately 50 pediatric liver transplants with live donors in low weight children in whom the hyper-reduction technique has been applied.
The aim of the present study is to describe postoperative morbidity and mortality and analyze overall and graft survival.
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
58
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Capital Federal、阿根廷、C1100AAF
- Hospital Italiano de Buenos Aires
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
5个月 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
All pediatric patients undergoing living donor liver transplantation with hyper-reduced liver grafts at the Liver Transplantation Unit of the Hospital Italiano de Buenos Aires between June 1997 and April 2018
描述
Inclusion Criteria:
- < or = 17 years old.
- Having undergone live donor liver transplantation.
- Having received hyper-reduced liver grafts
- At the Liver Transplantation Unit of the Hospital Italiano de Buenos Aires
- Between June 1997 and April 2018
Exclusion Criteria:
- > 17 years old.
- Cadaveric liver transplant
- Whole liver grafts.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Hyper-reduced liver recipients.
Low-weight children who underwent live donor liver transplantation with ultrasound-guided in situ left lateral segment graft hyper-reduction.
|
Live donor liver transplantation using non-anatomical in-situ ultrasound-guided reduction of left lateral segments with preparation of a graft that is larger than a monosegment, but smaller than Segments 2 and 3.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall survival at 1 year.
大体时间：Overall survival wil be reported at 1 year after liver transplantation.
|
Overall survival was defined as the time from surgery to death (all causes) or date of last follow-up, measured in months.
|
Overall survival wil be reported at 1 year after liver transplantation.
|
|
Overall survival at 3 years.
大体时间：Overall survival wil be reported at 3 years after liver transplantation.
|
Overall survival was defined as the time from surgery to death (all causes) or date of last follow-up, measured in months.
|
Overall survival wil be reported at 3 years after liver transplantation.
|
|
Overall survival at 10 years.
大体时间：Overall survival wil be reported at 10 years after liver transplantation.
|
Overall survival was defined as the time from surgery to death (all causes) or date of last follow-up, measured in months.
|
Overall survival wil be reported at 10 years after liver transplantation.
|
|
Graft survival at 1 year.
大体时间：Graft survival wil be reported at 1 year after liver transplantation.
|
Graft survival was defined as the time from surgery to the date of re-transplantation or re-entry to waiting list, measured in months.
|
Graft survival wil be reported at 1 year after liver transplantation.
|
|
Graft survival at 3 years.
大体时间：Graft survival wil be reported at 3 years after liver transplantation.
|
Graft survival was defined as the time from surgery to the date of re-transplantation or re-entry to waiting list, measured in months.
|
Graft survival wil be reported at 3 years after liver transplantation.
|
|
Graft survival at 10 years.
大体时间：Graft survival wil be reported at 10 years after liver transplantation.
|
Graft survival was defined as the time from surgery to the date of re-transplantation or re-entry to waiting list, measured in months.
|
Graft survival wil be reported at 10 years after liver transplantation.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Micaela Raices, Physician、Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- 学习椅：Matias E Czerwonko, Physician、Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- 学习椅：Victoria Ardiles, Physician、Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- 学习椅：Gustavo Boldrini, Physician、Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- 学习椅：Daniel D'Agostino, Physician、Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- 学习椅：José Marcó del Pont, Physician、Department of Pediatrics, Division of Pediatric Infectious Diseases, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- 学习椅：Juan Pekolj, Doctor、Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- 学习椅：Eduardo de Santibañes, Doctor、Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- 研究主任：Martin de Santibañes, Physician、Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年4月21日
初级完成 (实际的)
2018年6月3日
研究完成 (实际的)
2018年6月3日
研究注册日期
首次提交
2018年6月16日
首先提交符合 QC 标准的
2018年7月19日
首次发布 (实际的)
2018年7月20日
研究记录更新
最后更新发布 (实际的)
2018年7月20日
上次提交的符合 QC 标准的更新
2018年7月19日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.