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临床试验/NCT03578770
NCT03578770已完成不适用

Safety and Efficacy of the New 20 mm Lumen Apposing Metal Stent (Lams) for Endoscopic Treatment of Pancreatic and Peripancreatic Fluid Collections: a Large, International, Multicenter Study

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年1月1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
1,000
试验地点
1
主要终点
The investigators will evaluate the use of the new 20 mm Hot Axios in endoscopic transmural drainage through the reduction pof the bilirubin's value

研究概览

简要总结

Pancreatic fluid collections (PFC) can occur as a complication of acute and chronic pancreatitis. PFC include pancreatic pseudocysts (PP) and walled-off necrosis (WON).

The majorities of WON are asymptomatic and will resolve spontaneously. Endoscopic ultrasound (EUS)-guided drainage has become the preferred treatment in the management of symptomatic PFC, with significant advantages compared with surgical and percutaneous drainage. Successful endoscopic management of the pancreatic fluid collections depends on the type of PFC. Studies have shown that endoscopic drainage of PP is greater than 90%, while success for WON is at best between 50-65%. Differences in treatment outcome are attributed to the viscosity and debris content of the PFC. Traditionally, the EUS-guided drainage has been performed with placement of multiple plastic stents or fully covered self-expanding metal stent.

Recently, lumen-apposing metal stents (LAMS) have been developed. LAMS have been utilized for the access and drainage of pancreatic fluid collections (PFCs). To date, a variety of LAMS sizes have been commercially available and widely used. Studies have shown high technical success (89-100%) and high clinical success rate (93-100%). The larger diameter of LAMS facilitates better drainage of PFC contents when compared to the small caliber of plastic stents and allows necrosectomy in repeated sessions without the need for stent replacement.

A new LAMS with a larger (20mm) lumen diameter (the Hot Axios, Boston Scientific, Natick MA, USA) was released on the market, with the idea that a larger diameter would allow a faster drainage of PFCs and facilitate endoscopic necrosectomy. This is currently the largest diameter LAMS available.

Further studies are needed to determine the ideal size for a LAMS going forward to achieve maximal clinical benefit with minimal patient risk.

Aim of the investigator's study is to evaluate the safety and efficacy of the new 20 mm Hot Axios stent placement for EUS-guided transmural drainage of pancreatic fluid collections.

详细描述

Pancreatic fluid collections (PFC) can occur as a complication of acute and chronic pancreatitis. PFC include pancreatic pseudocysts (PP) and walled-off necrosis (WON).

The majorities of WON are asymptomatic and will resolve spontaneously. Endoscopic ultrasound (EUS)-guided drainage has become the preferred treatment in the management of symptomatic PFC, with significant advantages compared with surgical and percutaneous drainage. Successful endoscopic management of the pancreatic fluid collections depends on the type of PFC. Studies have shown that endoscopic drainage of PP is greater than 90%, while success for WON is at best between 50-65%. Differences in treatment outcome are attributed to the viscosity and debris content of the PFC. Traditionally, the EUS-guided drainage has been performed with placement of multiple plastic stents or fully covered self-expanding metal stent.

Recently, lumen-apposing metal stents (LAMS) have been developed. LAMS have been utilized for the access and drainage of pancreatic fluid collections (PFCs). To date, a variety of LAMS sizes have been commercially available and widely used. Studies have shown high technical success (89-100%) and high clinical success rate (93-100%). The larger diameter of LAMS facilitates better drainage of PFC contents when compared to the small caliber of plastic stents and allows necrosectomy in repeated sessions without the need for stent replacement.

A new LAMS with a larger (20mm) lumen diameter (the Hot Axios, Boston Scientific, Natick MA, USA) was released on the market, with the idea that a larger diameter would allow a faster drainage of PFCs and facilitate endoscopic necrosectomy. This is currently the largest diameter LAMS available.

Further studies are needed to determine the ideal size for a LAMS going forward to achieve maximal clinical benefit with minimal patient risk.

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Other
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
否

入选标准

  • •Consecutive patients who underwent EUS-guided 20 mm Hot Axios stent placement for PFCs were included.

排除标准

  • •No exclusion criteria

结局指标

主要结局

The investigators will evaluate the use of the new 20 mm Hot Axios in endoscopic transmural drainage through the reduction pof the bilirubin's value

时间窗: 24 months

次要结局

  • The investigators will assess the rate/severity of adverse events (AEs) (ASGE lexicon).(24 months)

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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