Clinical trial NCT06727851: ESGE-Quality Improvement in Endoscopy: ERCP
Official title: Quality Improvement in Endoscopy: Has the Implementation of the ESGE Guideline 2017 Led to a Reduction in Post-ERCP Pancreatitis? A Multicenter Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Post-ERCP Acute Pancreatitis
Keywords: performance measures
ESGE
post-ERCP pancreatitis
quality in endoscopy
Lead sponsor: Universität Münster
Sponsor class: OTHER
Collaborators: name: University of Kiel
name: University of Copenhagen
name: Johannes Gutenberg University Mainz
name: University Hospital Muenster
First posted: 2024-12-11
Enrollment: 1254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility 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:

-

Primary outcomes:
measure: Post-ERCP pancreatitis (PEP)
timeFrame: 2016 - 2025
Secondary outcomes:
measure: Adequate antibiotic prophylaxis before ERCP
timeFrame: 2016 - 2025
measure: Bile duct cannulation
timeFrame: 2016 - 2025
measure: Appropriate stent placement in patients with biliary obstruction below the hilum
timeFrame: 2016 - 2025
measure: Bile duct stone extraction
timeFrame: 2016 - 2025
Other outcomes:
Locations:
city: Warendorf
country: Germany
facility: University of Muenster, Josephs Hospital Warendorf, Academic Teaching Hospital
Study officials:
affiliation: Universität Münster
name: Dirk Domagk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akshintala VS, Kanthasamy K, Bhullar FA, Sperna Weiland CJ, Kamal A, Kochar B, Gurakar M, Ngamruengphong S, Kumbhari V, Brewer-Gutierrez OI, Kalloo AN, Khashab MA, van Geenen EM, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: an updated systematic review and meta-analysis of 145 randomized controlled trials. Gastrointest Endosc. 2023 Jul;98(1):1-6.e12. doi: 10.1016/j.gie.2023.03.023. Epub 2023 Mar 31.
citation: Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
citation: Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
citation: Domagk D, Oppong KW, Aabakken L, Czako L, Gyokeres T, Manes G, Meier P, Poley JW, Ponchon T, Tringali A, Bellisario C, Minozzi S, Senore C, Bennett C, Bretthauer M, Hassan C, Kaminski MF, Dinis-Ribeiro M, Rees CJ, Spada C, Valori R, Bisschops R, Rutter MD. Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2018 Nov;50(11):1116-1127. doi: 10.1055/a-0749-8767. Epub 2018 Oct 19.