Randomized controlled trial to assess early post operative outcomes of Extended Right lobe grafts {with Middle Hepatic vein} versus Modified right lobe grafts{Reconstruction of segment 5 and segment 8 Branches} in the Recipient following Live Donor Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Post Hepatectomy liver failure[PHLF}
研究概览
简要总结
This is a randomized parallel group trial designed to assess the early post operative outcomes in donors and recipients who undergoe Live donor liver transplantation.Outcomes in extended graft[with native middle hepatic vein] is compared with modified graft[with neo middle hepatic vein].It is conducted at a single centre [Amrita instititue of Medical sciences,Kochi,Kerala].Primary outcomes assessed in the recipient are Early allograft dysfunctio,.Primary graft non function,Small for size syndrome,Number of days in ICU and mortality at the end of 90 days.Primary outcomes assessed in the donor are Post hepatectomy liver failure,Volume regeneration after 60 days,Clavien Dindo Grading of post surgery morbidity and number of days in ICU after surgery.Change in post surgery liver parameters are also analysed in donor and recipient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 15.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •.Patients with liver disease who meet the criteria for live donor liver transplantation .Live donor suitable for extended right hepatectomy[with middle hepatic vein] a.Has a future liver remnant of more than 30% b.Live donor with adequate segment 4a drainage to left hepatic vein[usually a umblical vein] c.Steatosis less than 20% as assessed by L-S ratio on plain CT.
排除标准
- •.Thrombosed recipient portal Vein.
- •.Graft to recipient wight ratio less than 0.
- •.Venous drainage of segment 4 mainly to middle hepatic vein in donor .ABO incompatible liver transplants .Donor at or above 55 years of age.
结局指标
主要结局
Post Hepatectomy liver failure[PHLF}
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Post operative Clavien-Dindo score
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Number of days in hospital after surgery
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Recipient:
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Early Allograft Dysfuction[EAD]
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Small for size Syndrome[SFSS]
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Primary graft non function[PGNF}
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Patency of Middle hepatic vein
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Number of days in ICU
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Mortality at the end of 90 days
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
Donor:
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
CT based volume regeneration at the end of 60 days
时间窗: All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
次要结局
- Change in post surgery liver parameters in donor and recipient(Untill discharge/ 1Month [whichever comes later])