Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Recurrence of pancreatic pseudocyst
研究概览
简要总结
The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized studies have been conducted on the influence of pancreatic duct stenting for the patients' benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether pancreatic duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker clinical recovery and avoidance of recurrence of pancreatic pseudocysts.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pancreatic pseudocyst, at least 6 cm in diameter
- •symptomatic pancreatic pseudocyst
- •increasing size of pancreatic pseudocyst within 6 weeks
排除标准
- •Pregnancy
- •Age less than 18 years
- •Postoperative status preventing access to papilla
- •Allergy to contrast preventing from ERP
- •Missing informed consent to study
- •PTT above 1.5 times of normal, unless substituted
- •Platelet count less than 50.000/µl, unless substituted
- •Pancreatic ascites or fistula
- •Life expectancy less than 2 years
- •Percutaneously drained cysts are not part of the study
结局指标
主要结局
Recurrence of pancreatic pseudocyst
时间窗: two years
次要结局
未报告次要终点
研究者
Mark Ellrichmann
Head Interdisciplinary Endoscopy
University Hospital Schleswig-Holstein