Study Results
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Basic Information
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ENROLLING_BY_INVITATION
1254 participants
OBSERVATIONAL
2024-01-01
2026-07-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group before introduction of the QIC-initiative (before 2017)
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%.
No interventions assigned to this group
Group after introduction of the QIC-initiative (2017-2023)
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%.
No interventions assigned to this group
Prospective Group
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%.
No interventions assigned to this group
Eligibility Criteria
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Exclusion Criteria
* 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
\-
18 Years
ALL
No
Sponsors
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University of Kiel
OTHER
University of Copenhagen
OTHER
Johannes Gutenberg University Mainz
OTHER
University Hospital Muenster
OTHER
Universität Münster
OTHER
Responsible Party
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Principal Investigators
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Dirk Domagk, MD
Role: PRINCIPAL_INVESTIGATOR
Universität Münster
Locations
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University of Muenster, Josephs Hospital Warendorf, Academic Teaching Hospital
Warendorf, , Germany
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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Quality improvement in ERCP
Identifier Type: -
Identifier Source: org_study_id