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临床试验/NCT03165916
NCT03165916已完成不适用

A Randomized Controlled Prospective Study to Compare the Incidence of Biliary Complications After Liver Transplantation

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2014年9月15日最近更新:
适应症
干预措施

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

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

No Intervention

Subjects will undergo biliary reconstruction without stent placement.

Reconstruction with stent placement

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Scanga

Principal Investigator

Vanderbilt University Medical Center

研究点 (2)

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