Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Fistula | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Choledocholithiasis | — | UNRESOLVED | — |
| Choledocholithiasis With Acute Cholangitis | — | UNRESOLVED | — |
| Pancreatic Cancer Non-resectable | — | UNRESOLVED | — |
| Pancreatic Cancer Resectable | — | UNRESOLVED | — |
| Sclerosing Cholangitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic retrograde cholangiopancreatography (ERCP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with biliopancreatic pathology undergoing ERCP
- description
- Patients with biliopancreatic pathology who undergo ERCP are over 18 years of age and sign the informed consent.
- interventionNames
- Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)
Primary outcomes (5)
- measure
- To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry
- timeFrame
- Patients receiving antibiotic prophylaxis of at least one dose of any systemic antibiotic in a 12-hour interval prior to ERCP.
- description
- Number of participants receiving adequate antibiotic prophylaxis before ERCP.
- measure
- To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
- timeFrame
- Patients in whom biliary cannulation is achieved up to 1 hour after completion of ERCP.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: * Under 18 years of age * Unavailability of informed consent * Impossibility of follow-up.
References
Publications (9)
- BACKGROUNDMinisterio 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 20189503
- BACKGROUNDNass 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 34890695
- BACKGROUNDBrindise 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 33741091
- BACKGROUNDTheunissen 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 34107538
- BACKGROUNDLantinga 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 33080630
- 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.