NCT06727851

ESGE-Quality Improvement in Endoscopy: ERCP

Quality Improvement in Endoscopy: Has the Implementation of the ESGE Guideline 2017 Led to a Reduction in Post-ERCP Pancreatitis? A Multicenter Trial

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,254 (estimated)
• Sponsor: Universität Münster · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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".

Detailed description

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: 1. before introduction of the QIC-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data), 3. 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%. The investigators hope that this study will lead to even greater patient safety in the future by improving findings and examination quality and therefore reduce the incidence of post-ERCP pancreatitis. In addition, the aim is to harmonize the high endoscopic standards throughout Europe.

Conditions

• Post-ERCP Acute Pancreatitis

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-31
• Completion: 2026-07-01
• First posted: 2024-12-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: Germany