Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography
Prospective and Multicenter Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography
1 other identifier
observational
3,000
0 countries
N/A
Brief Summary
Endoscopic retrograde cholangiopancreatography (ERCP) is a technique which combines endoscopic and radiological vision and allows for therapeutic procedures on pathologies of the pancreas and bile duct. ERCP is a generally well tolerated procedure, nonetheless it is a complex technique that has a higher frequency of complications compared to most endoscopic procedures that can even be life-threatening. These complications are related to patient characteristics, experience of the endoscopist performing the procedure, and specific factors to the technique. Due to its complexity, quality assurance, operator training and auditing are required to increase success and minimize complications. There are quality indicators suggested by the main scientific societies in relation to technical aspects and complications, recommending their monitoring and auditing. Most endoscopy units lack records to monitor quality and complications, which prevents the assessment of quality and the identification of areas for improvement. Given the lack of evidence of the quality of ERCP in the Spanish population, the investigators will be conducting a multicenter, national prospective study that will include subjects who undergo ERCP. Patient data and technical aspects of the procedure will be recorded and all included patients will be monitored to identify complications. The quality indicators obtained within the registry will be compared with those established by scientific societies and the relationship between complications and technical factors will be analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2024
CompletedFirst Posted
Study publicly available on registry
November 1, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2028
ExpectedNovember 1, 2024
October 1, 2024
12 months
October 22, 2024
October 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry
Number of participants receiving adequate antibiotic prophylaxis before ERCP.
Patients receiving antibiotic prophylaxis of at least one dose of any systemic antibiotic in a 12-hour interval prior to ERCP.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants who achieved biliary cannulation.
Patients in whom biliary cannulation is achieved up to 1 hour after completion of ERCP.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants in whom stents are successfully placed in obstructions distal to the hilum.
Patients who successfully placed stents in obstructions distal to the hilum up to 1 hour after completion of ERCP.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants with successful removal of biliary tract stones.
Patients who successfully removed bile duct stones up to 1 hour after completion of ERCP.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants developing post-ERCP pancreatitis.
Patients who developed acute pancreatitis at 7 and 30 days after ERCP.
Secondary Outcomes (1)
To describe the severity of adverse events in ERCP according to the AGREE classification and their association with technical aspects of the procedure
Assessment of the development of adverse events at 24 hours according to the practice of each hospital; at 7 days and at 30 days after performing the ERCP by telephone call.
Study Arms (1)
Patients with biliopancreatic pathology undergoing ERCP
Patients with biliopancreatic pathology who undergo ERCP are over 18 years of age and sign the informed consent.
Interventions
Endoscopic retrograde cholangiopancreatography (ERCP)
Eligibility Criteria
Patients with biliopancreatic pathology for whom ERCP is performed in hospitals in Spain.
You may qualify if:
- All consecutive patients who have undergone an ERCP at participating centres from 1 November 2024 will be included. An ERCP will be considered to have been performed when an endoscope is introduced to access the duodenal papilla.
- These included patients must meet all of the following criteria:
- Over 18 years of age
- Signed informed consent.
You may not qualify if:
- Under 18 years of age
- Unavailability of informed consent
- Impossibility of follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (9)
Ministerio de Sanidad. Criterios homologados, acordados por el Consejo Interterritorial, que deben cumplir los CSUR para ser designados como de referencia del Sistema Nacional de Salud. Drenaje guiado por ecoendoscopia de la obstrucción biliopancreática compleja.
BACKGROUNDCotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PMID: 20189503BACKGROUNDNass KJ, Zwager LW, van der Vlugt M, Dekker E, Bossuyt PMM, Ravindran S, Thomas-Gibson S, Fockens P. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc. 2022 Jun;95(6):1078-1085.e8. doi: 10.1016/j.gie.2021.11.038. Epub 2021 Dec 8.
PMID: 34890695BACKGROUNDBrindise EM, Gerke H. Monitoring adverse events after ERCP: Call me maybe? Gastrointest Endosc. 2021 Apr;93(4):911-913. doi: 10.1016/j.gie.2020.08.036. No abstract available.
PMID: 33741091BACKGROUNDTheunissen F, van der Wiel SE, Ter Borg PCJ, Koch AD, Ouwendijk RJT, Slangen RME, Siersema PD, Bruno MJ; Trans.IT foundation study group. Implementation of mandatory ERCP registration in The Netherlands and compliance with European Society of Gastrointestinal Endoscopy performance measures: a multicenter database study. Endoscopy. 2022 Mar;54(3):262-267. doi: 10.1055/a-1499-7477. Epub 2021 Jun 9.
PMID: 34107538BACKGROUNDLantinga MA, Theunissen F, Ter Borg PCJ, Bruno MJ, Ouwendijk RJT, Siersema PD; Trans.IT foundation study group. Impact of the COVID-19 pandemic on gastrointestinal endoscopy in the Netherlands: analysis of a prospective endoscopy database. Endoscopy. 2021 Feb;53(2):166-170. doi: 10.1055/a-1272-3788. Epub 2020 Oct 20.
PMID: 33080630BACKGROUNDDomagk 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: 30340220BACKGROUNDJohnson G, Webster G, Boskoski I, Campos S, Golder SK, Schlag C, Anderloni A, Arnelo U, Badaoui A, Bekkali N, Christodoulou D, Czako L, Fernandez Y Viesca M, Hritz I, Hucl T, Kalaitzakis E, Kylanpaa L, Nedoluzhko I, Petrone MC, Poley JW, Seicean A, Vila J, Arvanitakis M, Dinis-Ribeiro M, Ponchon T, Bisschops R. Curriculum for ERCP and endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2021 Oct;53(10):1071-1087. doi: 10.1055/a-1537-8999. Epub 2021 Jul 26.
PMID: 34311472BACKGROUNDKochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, Khashab MA, Kalloo AN, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc. 2015 Jan;81(1):143-149.e9. doi: 10.1016/j.gie.2014.06.045. Epub 2014 Aug 1.
PMID: 25088919BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edgar Castillo-Regalado, MD
Hospital Universitario Germans Trias i Pujol (Badalona)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2024
First Posted
November 1, 2024
Study Start
November 1, 2024
Primary Completion
October 30, 2025
Study Completion (Estimated)
October 30, 2028
Last Updated
November 1, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Beginning 10 months and ending 2 years after the publication of results.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.
Data obtained through this study may be provided to qualified researchers with academic interest in ERCP and biliopancreatic diseases. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 10 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.