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临床试验/NCT04403893
NCT04403893已完成不适用

Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
AE and SAE events

研究概览

简要总结

One of the major roles of interventional EUS is biliary drainage (EUS-BD) as an alternative to ERCP-based biliary decompression.

In fact, even when performed by expert endoscopists, ERCP-based stenting fails in 5% of cases. In these cases, standard alternative approaches include surgical bypass and percutaneous transhepatic cholangiography and biliary drainage (PTBD). However, these procedures are associated with higher patient discomfort and prolonged hospital stay.

The most diffuse approach for EUS-BD are choledochoduodenostomy (CDS) or hepaticogastrostomy (HGS). As a matter of fact, since dedicate devices as lumen apposing metal stents (LAMS), have been adopted for CDS, we have been witnessing the escalation of such procedure.

On the other hand, the diffusion of EUS-HGS is still limited due to the complexity of the procedure and the lack of dedicated devices. However, recently a dedicated stent was conceived as asymmetrically covered and shaped in order to have its uncovered, tubular end into the intrahepatic ducts and the covered, flanged end into the gastric cavity, to reduce the risk of migration. The developement of such stent could further increase both the technical feasibility and the clinical outcomes of HGS in order to explore the whole potential of this procedure and to definitively find its role in biliary drainage algorithm.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • subjects with malignant bilio-pancreatic diseases with an indication to undergo biliary stent positioning for biliary drainage after ERCP failure.

排除标准

  • Age < 18 y
  • Contra-indication for endoscopy or interventional radiology
  • Unsigned informing consent form, ICF
  • Pregnancy

结局指标

主要结局

AE and SAE events

时间窗: 12 Months

To assess the technical safety for EUS-guided hepaticogastrostomy.

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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