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临床试验/NCT03030573
NCT03030573Unknown不适用

Reconstruction of Postcholecystectomy Bile Duct Injury and Bile Duct Defects With the Round Ligament

Beaujon Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Safety - absence of any severe complication or mortality related to the new procedure

研究概览

简要总结

The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament

详细描述

Classically, the bile duct defect after bile duct injury or resection is achieved by bilioenteric reconstruction. However bilioenteric anastomosis is associated with long term complications including intrahepatic bile ducts infection, specific complications related to the Roux en Y jejunal loop and eliminate the endoscopic access to intrahepatic bile ducts. The investigators had recently developed a new surgical technique to reconstruct the veins with the parietal peritoneum with excellent results. Accordingly the investigators decided to develop a new surgical technique in order to reconstruct the bile duct defects with the vascularized round ligament.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Radiological or operative diagnosis of bile duct Injury or defect
  • Can underwent surgical procedure

排除标准

  • The absence of the round ligament

结局指标

主要结局

Safety - absence of any severe complication or mortality related to the new procedure

时间窗: at 1 year

Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.

次要结局

  • Bile buct patency(at 3 year)

研究者

发起方
Beaujon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Safi Dokmak

MD

Beaujon Hospital

研究点 (2)

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