ESGE-Quality Improvement in Endoscopy: ERCP

• Conditions: Post-ERCP Acute Pancreatitis

• Registration Number: NCT06727851
• Lead Sponsor: Universität Münster

Brief 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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1254

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-ERCP pancreatitis (PEP)	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

Secondary Outcome Measures

Name	Time	Method
Adequate antibiotic prophylaxis before ERCP	2016 - 2025	Rate of adequate antibiotic prophylaxis before ERCP
Bile duct cannulation	2016 - 2025	Rate of successful bile duct cannulation
Appropriate stent placement in patients with biliary obstruction below the hilum	2016 - 2025	Rate of appropriate stent placement in patients with biliary obstruction below the hilum
Bile duct stone extraction	2016 - 2025	Rate of successful bile duct stone extraction

Trial Locations

Locations (1)

University of Muenster, Josephs Hospital Warendorf, Academic Teaching Hospital; 🇩🇪 Warendorf, Germany