NCT02971579已完成不适用
A Network on the Quality of ERCP, on the Organization of the Endoscopic Units and on the Training of the Endoscopists in Italy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Complications rate
研究概览
简要总结
This is a prospective observational longitudinal study
Aim of the study is to collect information:
- on the organization models of the Endoscopic Units performing ERCP in Italy
- on the previous and/or ongoing training of the endoscopists performing ERCP
- on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome
详细描述
Quality of ERCP in Italy has been object of various, mainly retrospective studies in Italy, but it has never systematically and prospectively evaluated in a large prospective series.
Moreover, the study aim at collecting data on the organization models of the Endoscopic Units performing ERCP in Italy; on the previous and/or ongoing training of the endoscopists performing ERCP; on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome of the procedure
The study consists of 3 phases:
- Collection of the information on the Endoscopic Unit and on the endoscopists who performed ERCP in the center
- Collection of data regarding consecutive ERCPs performed in adult patients in each center including demographic, clinical and procedural information
- Definition of the the outcome of ERCP assessed after 30 days from the procedure
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate in the study
排除标准
- •Informed consent not subscribed
结局指标
主要结局
Complications rate
时间窗: 30 days
Occurrence of post -ERCP complications
次要结局
- Rate of repeated procedure(30 days)
研究者
研究点 (1)
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