Multicenter Retrospective International Survey to Evaluate the Rate of AXIOS-related AEs in Endoscopic Transmural Drainage of Pancreatic Fluid Collections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 主要终点
- The investigators will evaluate the use of AXIOS in Endoscopic transmural drainage of Pancreatic fluid collections (PFC)
研究概览
简要总结
This is a retrospective study. Electronic chart review at respective centers will be the only database used. No patient contact or additional procedures will be conducted.
The main objectives are:
A) To evaluate the use of AXIOS in Endoscopic transmural drainage of Pancreatic fluid collections (PFC) in terms of clinical success and technical success.
B) To assess the rates, management, need for re-intervention, need for surgery, etiology and characteristics of Pancreatic fluid collections (PFC) on the occurrence of AXIOS- related related adverse events(AE).
详细描述
This is a retrospective study. Electronic chart review at respective centers will be the only database used. No patient contact or additional procedures will be conducted.
Data that will be recorded on review of electronic medical record database include:
I. Demographics (age, gender) II. Indication for procedure III. Diagnosis and findings including radiologic findings IV. Prior endoscopy treatments V. Type and number of stents used VI. Pancreatic fluid collection location and measurements VII. Procedure time VIII. Technical success IX. Clinical success X. Adverse events XI. Management of adverse events XII. Recurrence of pancreatic fluid collections XIII. Follow-up time
The above data will be collected and recorded in an excel sheet. The data collection will be completely de-identified and password protected. The file will be emailed using an institution email and encrypted. The password will be given in a separate email or by phone call.
Inclusion:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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 undergoing endoscopic management of pancreatic fluid collections between January 2011 to June 2017
排除标准
- •Age under 18
结局指标
主要结局
The investigators will evaluate the use of AXIOS in Endoscopic transmural drainage of Pancreatic fluid collections (PFC)
时间窗: 24 months
次要结局
- The investigators will assess the rates, management, need for re-intervention, need for surgery, etiology and characteristics of Pancreatic fluid collections (PFC) on the occurrence of AXIOS- related related adverse events(AE).(24 months)