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临床试验/NCT04705740
NCT04705740已完成不适用

Influence of the Endoscopist Case Volumen on Endoscopic Retrograde CholangioPanceratography Outcomes

Fundacion Miguel Servet1 个研究点 分布在 1 个国家目标入组 2,561 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,561
试验地点
1
主要终点
Adverse effects

研究概览

简要总结

Retrospective analysis on a prospective database that analyzes the influence of the number of endoscopists on the Endoscopic Retrograde CholangioPanceratography result.

详细描述

The number of Endoscopic Retrograde CholangioPanceratographys (ERCP) performed annually by an endoscopist has been shown to influence the outcomes of the procedure, especially on the papillary cannulation rate and the adverse effects rate. The number of ERCPs performed annually by each endoscopist is directly related to the number of endoscopists who perform this procedure, since the total number of ERCPs performed annually at each center is usually constant.

The hypothesis of this study is that the number of endoscopists who perform ERCP in a hospital influences the results of the procedure, so that the fewer the number of endoscopists the better the results.

To evaluate this hypothesis, the investigators have designed a retrospective study analyzing data from a prospectively filled database, which includes all ERCPs performed in our center from September 2013 to June 2020. For organizative reasons unrelated to the endoscopy unit, in the center it has beed progressively reduced the number of endoscopists who perform ERCP, starting from 5 endoscopists at the beginning of the study to 3 endoscopists at the end of the study inclusion period. In fact, three different periods of similar duration can be distinguished: September 2013 to August 2015 (5 endoscopists), September 2015 to December 2017 (4 endoscopists) and January 2018 to June 2020 (3 endoscopists).

The outcomes obtained with ERCP in these three periods will be analyzed and compared, assessing the cannulation rate and the adverse effects rate as the main comparison parameters.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing ERCP with written informed consent given
  • Staff allocated in the endoscopy unit

排除标准

  • Rejection to participate in the study
  • ERCP procedures performed by fellows in training

结局指标

主要结局

Adverse effects

时间窗: Up to 1 month after intervention

Rate of adverse effect assessed by the ASGE classification

Papillary cannulation

时间窗: During the procedure

Rate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically

次要结局

  • Complexity level of ERCP(During the ERCP procedure)
  • Individual adverse effects(Up to 1 month after intervention)
  • Therapeutics performed with ERCP(During the ERCP procedure)

研究者

发起方
Fundacion Miguel Servet
申办方类型
Other
责任方
Sponsor

研究点 (1)

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