Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 6:23 PM
Study NCT ID:
NCT06727851
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-11
First Post:
2024-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ESGE-Quality Improvement in Endoscopy: ERCP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1254}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-ERCP pancreatitis (PEP)', 'timeFrame': '2016 - 2025', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Adequate antibiotic prophylaxis before ERCP', 'timeFrame': '2016 - 2025', 'description': 'Rate of adequate antibiotic prophylaxis before ERCP'}, {'measure': 'Bile duct cannulation', 'timeFrame': '2016 - 2025', 'description': 'Rate of successful bile duct cannulation'}, {'measure': 'Appropriate stent placement in patients with biliary obstruction below the hilum', 'timeFrame': '2016 - 2025', 'description': 'Rate of appropriate stent placement in patients with biliary obstruction below the hilum'}, {'measure': 'Bile duct stone extraction', 'timeFrame': '2016 - 2025', 'description': 'Rate of successful bile duct stone extraction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['performance measures', 'ESGE', 'post-ERCP pancreatitis', 'quality in endoscopy'], 'conditions': ['Post-ERCP Acute Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '37004815', 'type': 'BACKGROUND', '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.'}, {'pmid': '17509029', 'type': 'BACKGROUND', '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.'}, {'pmid': '31863440', 'type': 'BACKGROUND', '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.'}, {'pmid': '30340220', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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".', 'detailedDescription': '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).\n\nThe 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.\n\nThe study will compare the quality development in endoscopy based on following time intervals:\n\n1. before introduction of the QIC-initiative (before 2017)\n2. after the introduction of the initiative (2017-2023) (both retrospective data),\n3. prospectively, from 2024 onwards.\n\nThe 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%.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria\n\n* Age under 18 years\n* Inability to understand information for participation\n* Refusal of participation, missing cooperativity, e.g., due to age or disease\n* Pregnant or lactating patients\n* Patients with \\> 1 ERCP during the hospital stay: only the initial ERCP will be evaluated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:nclusion criteria Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria\n\nExclusion criteria\n\n* Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria\n* Age under 18 years\n* Inability to understand information for participation\n* Refusal of participation, missing cooperativity, e.g., due to age or disease\n* Pregnant or lactating patients\n* Patients with \\> 1 ERCP during the hospital stay: only the initial ERCP will be evaluated\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06727851', 'acronym': 'QIC_ERCP', 'briefTitle': 'ESGE-Quality Improvement in Endoscopy: ERCP', 'organization': {'class': 'OTHER', 'fullName': 'Universität Münster'}, 'officialTitle': 'Quality Improvement in Endoscopy: Has the Implementation of the ESGE Guideline 2017 Led to a Reduction in Post-ERCP Pancreatitis? A Multicenter Trial', 'orgStudyIdInfo': {'id': 'Quality improvement in ERCP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group before introduction of the QIC-initiative (before 2017)', 'description': '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%.'}, {'label': 'Group after introduction of the QIC-initiative (2017-2023)', 'description': '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%.'}, {'label': 'Prospective Group', 'description': '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%.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48231', 'city': 'Warendorf', 'country': 'Germany', 'facility': 'University of Muenster, Josephs Hospital Warendorf, Academic Teaching Hospital', 'geoPoint': {'lat': 51.95109, 'lon': 7.98756}}], 'overallOfficials': [{'name': 'Dirk Domagk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universität Münster'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Münster', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Kiel', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, {'name': 'University Hospital Muenster', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}