Quality Improvement in Endoscopy: Has the Implementation of the ESGE Guideline 2017 Led to a Reduction in Post-ERCP Pancreatitis? A Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,254
- 试验地点
- 1
- 主要终点
- Post-ERCP pancreatitis (PEP)
研究概览
简要总结
The primary aim of the present study is to compare the incidence of post-ERCP pancreatitis (PEP) before and after the implementation of the QIC-guideline in 2017: "Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative".
详细描述
In 2017, a new guideline addressing the quality in ERCP entitled "Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative" was published. The focus of the quality improvement committee (QIC) of the ESGE is to ensure high standard of all endoscopy examinations throughout Europe by adhering to quality-improving factors (key performance indicators and minor performance indicators as defined by the ESGE).
The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Endoscopy (ESGE) will actually lead to an improvement in quality.
The study will compare the quality development in endoscopy based on following time intervals:
- before introduction of the QIC-initiative (before 2017)
- after the introduction of the initiative (2017-2023) (both retrospective data),
- prospectively, from 2024 onwards.
The primary endpoint of this study will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •nclusion criteria Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria
- •Exclusion criteria
- •Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria
- •Age under 18 years
- •Inability to understand information for participation
- •Refusal of participation, missing cooperativity, e.g., due to age or disease
- •Pregnant or lactating patients
- •Patients with > 1 ERCP during the hospital stay: only the initial ERCP will be evaluated
排除标准
- 未提供
结局指标
主要结局
Post-ERCP pancreatitis (PEP)
时间窗: 2016 - 2025
Comparison of the incidence of PEP before and after the implementation of the guideline. i. Clinical illness with typical pain (physical examination: pain in the upper belly with/without radiation to the back, tenderness when touching the belly) ii. laboratory testing with 3x increase of lipase (or amylase) iii. Characteristic findings in CE-CT, MRI or transabdominal sonography iv. Requiring extension of hospital stay
次要结局
- Adequate antibiotic prophylaxis before ERCP(2016 - 2025)
- Bile duct cannulation(2016 - 2025)
- Appropriate stent placement in patients with biliary obstruction below the hilum(2016 - 2025)
- Bile duct stone extraction(2016 - 2025)