NCT03022110Unknown不适用
Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial
Yiqi Du0 个研究点目标入组 106 人开始时间: 2017年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 主要终点
- Cyst recurrence rate
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 traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment.
详细描述
Inclusion criteria
- 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
Exclusion criteria
- 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
结局指标
主要结局
Cyst recurrence rate
时间窗: up to 12 months
次要结局
- Complication rate(up to 12 months)
- Technical success rate(up to 48 hours)
- Clinical success rate(up to 12 months)
研究者
Yiqi Du
Professor
Changhai Hospital
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