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Enrolling by Invitation

NCT Number: NCT06727851

ESGE-Quality Improvement in Endoscopy: ERCP

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".

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Muenster, Josephs Hospital Warendorf, Academic Teaching Hospital

Warendorf, 48231, Germany

About this study

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%.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Post-ERCP pancreatitis (PEP)

    Time frame: 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 outcomes

  1. Adequate antibiotic prophylaxis before ERCP

    Time frame: 2016 - 2025

    Rate of adequate antibiotic prophylaxis before ERCP

  2. Bile duct cannulation

    Time frame: 2016 - 2025

    Rate of successful bile duct cannulation

  3. Appropriate stent placement in patients with biliary obstruction below the hilum

    Time frame: 2016 - 2025

    Rate of appropriate stent placement in patients with biliary obstruction below the hilum

  4. Bile duct stone extraction

    Time frame: 2016 - 2025

    Rate of successful bile duct stone extraction

Sponsors and collaborators

Lead sponsor

Universität Münster

Other

Collaborators

  • Johannes Gutenberg University Mainz
  • University Hospital Muenster
  • University of Copenhagen
  • University of Kiel

Registry information

Official study title

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

Acronym: QIC_ERCP

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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