Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 256
- 主要终点
- clinical success
研究概览
简要总结
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.
详细描述
Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with ages from 18-80 years old
- •Subject with pancreatic pseudocysts confirmed by CT
- •Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
- •The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
- •Subject has the symptoms related with the pseudocyst
- •The consent form has been signed
排除标准
- •Subject is younger than 18 years or older than 80 years
- •Pancreatic pseudocyst communicate with the main pancreatic duct
- •Subject can't accept the endoscopic procedure
- •Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
- •The distance between gastric and the wall of the pseudocyst is more than 1 cm
- •Subject with 2 or more than 2 cysts
- •Subject has blood coagulation dysfunction
- •Pregnant or subject has mental disorders
研究组 & 干预措施
Lumen-apposing metal stent(LAMS)
Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS
干预措施: Lumen-apposing metal stent (LAMS) (Device)
Double pigtail plastic stent(DPPS)
Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS
干预措施: Double pigtail plastic stent (DPPS) (Device)
结局指标
主要结局
clinical success
时间窗: uo to 1 months
The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased
次要结局
- adverse event(up to 2months/ stent remove)
- recurrence rate(up to 12 months)
- technical success(up to 48 hours)
研究者
Yiqi Du
Professor
Changhai Hospital