Efficacy and Safety of Double-pigtail Plastic Versus Lumen-apposing Metal Stents for Transmural Drainage of Walled-off Necrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- clinical success (clinical improvement and resolution of WON)
研究概览
简要总结
Walled-off necrosis (WON) is defined as an encapsulated collection of solid and liquid necrotic material that is usually formed 4 weeks after an episode of acute necrotizing pancreatitis. As the advances in endoscopic techniques and accessories, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON). This article aims to compare the efficacy and safety of a double mushroom head metal stent and a double pigtail plastic stent in the treatment of encapsulated necrosis of the pancreas.
详细描述
According to the revised Atlanta classification, pancreatic fluid collections (PFCs) include acute peripancreatic fluid collections(APFCs) and acute necrotic collections(ANCs), which, over time, turn into pancreatic pseudocysts (PPs) and walled-off pancreatic necrosis (WON). Drainage of these PP and WON is required when they increase in size and become infected or become symptomatic.
Traditionally, WON has been managed surgically, however, surgical necrosectomy is associated with substantial morbidity and mortality, particularly when pursued early. In recent years, with the development of minimally invasive techniques, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON).
Double-pigtail plastic stents(DPPS) is the earliest stent used for WON drainage in ultrasound endoscopy, however, These stents are limited by their small diameter leading to increased risk of stent obstruction. Recently, lumen-apposing metal stents (LAMS) have been increasingly used because of the advantage of better lumen apposition and wider diameter, improving access for endoscopic debridement. However, more adverse events(AEs) such as bleeding have been reported.
This article aims to compare the efficacy and safety of DPPS and LAMS in the treatment of Walled-off necrosis
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
- •Obtention of a written informed consent
- •According to Revised Atlanta Classification, abdominal CT/MRI and EUS were diagnosed as WON
- •The diameter of WON ≥6cm
- •Patient capable of fill in the quality of life questionnaire
- •The distance between the EUS-probe and WON was < 1 cm.
排除标准
- •No written informed consent
- •pancreatic cystic tumor, pancreatic cancer and other benign and malignant tumors
- •pancreatic pseudocyst
- •WON too far from the stomach and duodenum to perform endoscopic drainage
- •Serious abnormalities in liver and kidney function and coagulation function
- •Pregnant, parturient or breastfeeding women
研究组 & 干预措施
LAMS group
place LAMS under endoscopic ultrasound. Direct endoscopic necrosectomy(DEN) was performed through the LAMS with a forward viewing gastroscope if necessary
干预措施: endoscopic ultrasound (Procedure)
LAMS group
place LAMS under endoscopic ultrasound. Direct endoscopic necrosectomy(DEN) was performed through the LAMS with a forward viewing gastroscope if necessary
干预措施: lumen-apposing metal stent (Device)
DPPS group
Place DPPS under endoscopic ultrasound. When required, DEN was performed once the cystogastrostomy/duodenostomy tract had matured. This was done by first removing the stents followed by dilation of the tract with a radial expansion balloon and insertion of a forward viewing gastroscope through the tract for DEN
干预措施: endoscopic ultrasound (Procedure)
DPPS group
Place DPPS under endoscopic ultrasound. When required, DEN was performed once the cystogastrostomy/duodenostomy tract had matured. This was done by first removing the stents followed by dilation of the tract with a radial expansion balloon and insertion of a forward viewing gastroscope through the tract for DEN
干预措施: double-pigtail plastic stents (Device)
结局指标
主要结局
clinical success (clinical improvement and resolution of WON)
时间窗: two months
compare rates of WON resolution in patients with LAMS and DPPS for treatment of walled-off necrosis
次要结局
- Adverse Events(two months)
研究者
Jianfeng Yang
Deputy irector
First People's Hospital of Hangzhou