Lumen Apposing Metal Stents With and Without a Coaxial Double Pigtail Stent in the Management of Pancreatic Fluid Collections
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
- 否
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
JOAN B GORNALS
PhD
Hospital Universitari de Bellvitge
