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Набор по приглашению NCT06727851

ESGE-Quality Improvement in Endoscopy: ERCP

— Наблюдательное Post-ERCP Acute Pancreatitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Post-ERCP Acute Pancreatitis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
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Официальное название

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

Обзор

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".

Подробное описание

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.

Первичные конечные точки

  • Post-ERCP pancreatitis (PEP) [Срок оценки: 2016 - 2025]
Вторичные конечные точки (4)
  • Adequate antibiotic prophylaxis before ERCP [Срок оценки: 2016 - 2025]
  • Bile duct cannulation [Срок оценки: 2016 - 2025]
  • Appropriate stent placement in patients with biliary obstruction below the hilum [Срок оценки: 2016 - 2025]
  • Bile duct stone extraction [Срок оценки: 2016 - 2025]

Критерии участия

Inclusion Criteria:nclusion criteria Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria

Критерии исключения

  • 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

Критерии исключения

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • University of Muenster, Josephs Hospital Warendorf, Academic Teaching Hospital — Warendorf

Публикации

  • 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.2 PMID 37004815
  • 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
  • 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
  • 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 PMID 30340220

Идентификаторы

NCT: NCT06727851 · Quality improvement in ERCP

Первоисточники (государственные реестры)

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