Sonographic Based Visualization Instead of X-ray of Pancreatic Stents Placed to Prenvent Post-ERCP Pancreatitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Confirmation of a new algorithm to remove a prophylactic pancreatic stent placed to prevent post-ERCP pancreatitis by using sonography as first approach and compare the findings statistically in a pivot table to x-ray and endoscopy.
研究概览
简要总结
The present study is a prospective, single-center study. A total of 88 patients, who had placed a pancreatic stent for preventing post-ERCP pancreatitis, will be included in the study. Aim of the study is to establish a new algorithm based on a sonographic approach to remove the placed pancreatic stents. Another aim is to compare high-end sonographic devices with devices of medium price scale one's used on the ward.
On the day of removal of the pancreatic stent, all patients receive a sonography by an experienced investigator on the ward and by another, uninformed investigator with a high-end device. If a pancreatic stent is visualized in the pancreatic duct, the patient will have an esophagogastroduodenoscopy to remove the pancreatic stent. If sonography cannot find a pancreatic stent in the pancreatic duct an x-ray will be performed as suggested by the European and international guidelines. If the pancreatic stent spontaneously dislocated into the small bowel tract according to x-ray, no further investigation will be performed. If a stent is visulized in situ by x-ray, it will be removed by endoscopyl.
Statistical analysis will be done in cooperation with the statistical biomedical institute oft he university hospital in Frankfurt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Neither the investigator nor the patient will know before the sonographic approach, if the pancreatic stent is still in place. The diagnosis will be confirmed either by endoscopic findings or by x-ray depending on sonographic diagnosis and further algorithm.
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
- •placement of prophylactic pancreatic stent to prevent post-ERCP-pancreatitis
- •age of at least 18 years
- •written informed consent
排除标准
- •diseases that prevent sonography, x-ray or esophagogastroduodenoscopy
- •no given consent
- •other indication for pancreatic stenting
结局指标
主要结局
Confirmation of a new algorithm to remove a prophylactic pancreatic stent placed to prevent post-ERCP pancreatitis by using sonography as first approach and compare the findings statistically in a pivot table to x-ray and endoscopy.
时间窗: The entire procedure will take place within one hour.
A new algorithm is supposed to be tested that starts with a sonography to display a pancreatic stent. If the pancreatic stent can be visualized in the pancreatic duct, an esophagogastroduodenoscopy will be performed directly to remove the stent. If the stent cannot be displayed by sonography, x-ray will be performed as commonly suggested by the European and international guidelines. Therefore, the main goal of the study is to implement sonography before further diagnostic modalities to confirm prophylactic pancreatic stents position in the pancreatic duct.
次要结局
- Comparison of the findings of high-end sonographic devices and the findings of medium prize sonographic devices used on the ward by using a pivot table.(Both will take place within 30 minutes.)
- Univariate analysis of the baseline characteristics compared to the results of sonographic findings to evaluate risk factors of false sonographic findings by using a Case report form to collect the data.(The entire procedure will take place within one hour.)
研究者
Georg Dultz
Principal Investigator
Johann Wolfgang Goethe University Hospital