ESGE-Quality Improvement in Endoscopy: ERCP

NCT06727851 | Enrolling By Invitation

• 1 other identifier: Quality improvement in ERCP
• Study Type: observational
• Target: 1,254
• Locations: 1 country
• Sites: 1

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".

Conditions

Post-ERCP Acute Pancreatitis

Keywords

performance measures; ESGE; post-ERCP pancreatitis; quality in endoscopy

Outcome Measures

Primary Outcomes (1)

• Post-ERCP pancreatitis (PEP)

  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

  2016 - 2025

Secondary Outcomes (4)

• Adequate antibiotic prophylaxis before ERCP

  2016 - 2025

• Bile duct cannulation

  2016 - 2025

• Appropriate stent placement in patients with biliary obstruction below the hilum

  2016 - 2025

• Bile duct stone extraction

  2016 - 2025

Study Arms (3)

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%.

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%.

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%.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Münster: lead
• University of Kiel: collaborator
• University of Copenhagen: collaborator
• Johannes Gutenberg University Mainz: collaborator
• University Hospital Muenster: collaborator

Study Sites (1)

University of Muenster, Josephs Hospital Warendorf, Academic Teaching Hospital

Warendorf, 48231, Germany

Location

Related Publications (4)

• 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.

  PMID: 37004815 BACKGROUND

• 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.

  PMID: 17509029 BACKGROUND

• 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.

  PMID: 31863440 BACKGROUND

• 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.

  PMID: 30340220 BACKGROUND

Study Officials

• Dirk Domagk, MD

  Universität Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-11

Locations

DE (1)