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临床试验/NCT03282539
NCT03282539已完成不适用

Lumen Apposing Metal Stents With and Without a Coaxial Double Pigtail Stent in the Management of Pancreatic Fluid Collections

Hospital Universitari de Bellvitge1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Adverse events

研究概览

简要总结

The study evaluates the security of LAMS with ando without a coaxial double pigtail plastic stent in the management of pancreatic fuid collections.

详细描述

The introduction of lumen-apposing metal stents (LAMS) represented a great improvement in the EUS-guided transmural drainage of pancreatic fluid collections (PFCs). It is postulated safer than other types of stents due to the presence of bilateral anchoring flanges, designed to appose the stomach or duodenum to the PFC wall minimizing the risk of perforation or peritoneal leakage. In addition, the larger lumen diameter facilitates the drainage of PFC, specially the walled-off pancreatic necrosis (WOPN). However, secondary adverse effects such as infection due to complete or partial stent obstruction, migration, bleeding or buried LAMS syndrome have also been related . The placement of a coaxial double pigtail plastic within the LAMS has been reported beneficial in order to avoid external migration or the lumen obstruction and to the prevention of bleeding and other adverse events. The aim of this study was to evaluate the efficacy and safety of LAMS with and without a coaxial double pigtail plastic stent in the EUS-guided transmural drainage of PFCs.

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

  • Patients with pancreatic fluid collections and indication of drainage.
  • EUS-guided trasmural drainage wiht lumen apposing metal stents.
  • Criteria for drainage were as specified by the Working Group of the International Association of Pancreatology.

排除标准

  • Other types of collections and stents
  • Severe coagulopathy (protombin time > 1,5) or thrombocytopenia (platelet count < 50 x 109/L)
  • PFCs with a previous attempt failed of EUS-guided transmural drainage
  • Age younger than 18 years

结局指标

主要结局

Adverse events

时间窗: Outcomes will be assessed 6 months after the inclusion of last patient.

Defined and graded according to the ASGE lexicon's severity grading system

次要结局

未报告次要终点

研究者

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

JOAN B GORNALS

PhD

Hospital Universitari de Bellvitge

研究点 (1)

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