ESGE-Quality Improvement in Endoscopy: ERCP (QIC_ERCP)

Universität Münster

Status: Invitation-only

Conditions: Post-ERCP Acute Pancreatitis

Study type: Observational

Funder types: Other

Identifiers

NCT06727851

Quality improvement in ERCP

Details and patient eligibility

About

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".

Full 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.

Enrollment: 1,254 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

1,254 participants in 3 patient groups

Group before introduction of the QIC-initiative (before 2017)

Description:

The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal 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 focus of this study we 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%.

Group after introduction of the QIC-initiative (2017-2023)

Description:

The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal 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 focus of this study we 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%.

Prospective Group

Description:

The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal 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 focus of this study we 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%.