Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Short time complication rate
研究概览
简要总结
Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In modern medicine the preferred way to perform such a drainage is by the means of endoscopic ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed in different scenarios. The cyst appearance and the drainage stents and/or technique may impact the clinical outcome.
This study is a prospective, single-center observational study on the outcome after EUS-guided drainage of pancreatic pseudocysts.
详细描述
Patintes referred to Sahlgrenska University hospital for an EUS-guided drainage of a pseudocyst are eligible for inclusion. The drainage is performed at the discretion of an experienced endosonographer. Thus, the equipment and the technique used may vary among patients but no randomization is done before the procedure. Intraprocedural variables are registered as well as data and outcome parameters from the clinical follow up according to below.
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
- •All patients >18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage
排除标准
- •Patients unwilling to participate or unable to understand or sign the informed consent
- •Patients with no need for pseudocyst drainage as assessed by the endosonographer
结局指标
主要结局
Short time complication rate
时间窗: Uo to 48 hours
The number of EUS-procedure-related complications such as bleeding, infection and death.
Repeated drainage frequency
时间窗: Up to 3 months
A successful drainage means no need for additional drainage procedures. The need for a repeated drainage is to be regarded as a therapeutic failure. The number of repeated procedures due to the need for additional drainage is recorded.
次要结局
- Hospital stay(Up to 30 days)
- Long time complication rate(Up to 6 months)
研究者
Per Hedenström
MD
Sahlgrenska University Hospital