A Randomized Controlled Prospective Study to Compare the Incidence of Biliary Complications After Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Number of Participants With Biliary Complications
研究概览
简要总结
A randomized prospective study will be conducted of patients at Vanderbilt University Medical Center who undergo liver transplantation from March 2014 until approximately 120 patients are randomized. Patients will be randomized to undergo biliary reconstruction with and without stent placement.
详细描述
The risk of biliary complications can be related to the type of liver transplant performed and the technique used for reconstruction of the bile duct. One of the main techniques of performing biliary reconstruction is a choledocholedochostomy which can be performed over an anastomotic stent. Although placement of biliary stents is routine practice in many liver transplant centers around the country, there is no clear evidence to support their use. As of now both the placement and non-placement of a stent are essentially "standard of care". In the investigators' center, many of the transplant surgeons now perform the biliary anastomosis over a pediatric feeding tube which is used as a stent. The practice of using stents in biliary anastomosis is not uniform and there are no established guidelines to support their indiscriminate application. The investigators have designed a prospective randomized trial to evaluate the effect of stent placement on biliary complications and its effect on morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •will be undergoing liver transplantation
- •able to give informed consent
排除标准
- 未提供
研究组 & 干预措施
Reconstruction without stent placement
Subjects will undergo biliary reconstruction without stent placement.
Reconstruction with stent placement
Subjects will undergo biliary reconstruction with stent placement at the anastomosis site.
干预措施: Bard 5 Fr diameter feeding tube (Device)
结局指标
主要结局
Number of Participants With Biliary Complications
时间窗: 12 months after transplantation
Biliary complications include biliary strictures, biliary leaks, cholangitis, and stones. The investigators will compare the number of complications between the group that receives the stent and the group that does not.
次要结局
未报告次要终点
研究者
Andrew Scanga
Principal Investigator
Vanderbilt University Medical Center
