Clinical trial NCT06670547: Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography
Official title: Prospective and Multicenter Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Choledocholithiasis
Choledocholithiasis With Acute Cholangitis
Cholangiocarcinoma
Sclerosing Cholangitis
Pancreatic Cancer Resectable
Pancreatic Cancer Non-resectable
Biliary Fistula
Keywords: ERCP ADVERSE EVENTS
PERFORMANCE MEASURES
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: Spanish Society of Digestive Endoscopy
First posted: 2024-11-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biliopancreatic pathology for whom ERCP is performed in hospitals in Spain.

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.

Detailed description: Currently, endoscopic retrograde cholangiopancreatography (ERCP) is a well-established procedure that is in continuous development, with an incidence and severity of adverse events (AEs) that differ substantially from those related to other endoscopic procedures, reaching up to 14.7% and with a mortality rate of 0.7%, even in expert centers 1. For this reason, it is essential to ensure the quality of ERCP procedures, requiring optimal training, capacity building and auditing to increase the success of the procedure and minimize the risk of complications 2.

In recent years, the evaluation of the quality of ERCP has gained interest among health professionals and patient organizations. In 2018, the European Society of Gastrointestinal Endoscopy (ESGE) and the United European Gastroenterology (UEG) published key quality recommendations for ERCP and endoscopic ultrasonography with the aim of encouraging healthcare professionals to implement these performance targets at national level 3. For ERCP there are 5 recommendations including adequate antibiotic prophylaxis before ERCP (at least 90%), biliary cannulation rate (at least 90%), adequate stent placement in patients with sub-hilum obstruction (at least 95%), removal of bile duct stones (at least 90%) and post-ERCP pancreatitis (less than 10%).

Following this line, endoscopists in the Netherlands have been using a mandatory nationwide quality register since 2016 (Trans.IT database; Rotterdam, the Netherlands), which provides information on the quality of ERCP 4. They have recently published the analysis of this register in relation to the ESGE quality recommendations. 5671 procedures performed by 57 endoscopists in 11 centres were included. Three key quality indicators were met: successful biliary cannulation, adequate placement of stents for biliary obstruction and removal of bile duct stones with a high overall success rate. These robust data from routine clinical practice also allow us to identify areas for improving the quality of ERCP, for example, successful cannulation of native papillae below 90% for endoscopists performing fewer than 50 procedures per year or the rate of adequate placement of biliary stents below 90% in endoscopists performing fewer than 25 procedures per year 5. Unfortunately, the rate of pancreatitis, which is the most appropriate indicator of the rate of adverse events, was not evaluated in this registry.

In our view, the collection of data at a national level is of undoubted value to identify areas for improvement and to guarantee quality in ERCP, however, there are no state databases in our setting.

The present study aims to evaluate the quality indicators of ERCP recommended by the ESGE-UEG in a Spanish prospective registry and to describe the real incidence of adverse events in clinical practice, and their association with technical aspects of the procedure.

Eligibility criteria: 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.

Primary outcomes:
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.
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.
measure: To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
timeFrame: Patients who successfully placed stents in obstructions distal to the hilum up to 1 hour after completion of ERCP.
measure: To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
timeFrame: Patients who successfully removed bile duct stones up to 1 hour after completion of ERCP.
measure: To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
timeFrame: Patients who developed acute pancreatitis at 7 and 30 days after ERCP.
Secondary outcomes:
measure: To describe the severity of adverse events in ERCP according to the AGREE classification and their association with technical aspects of the procedure
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Germans Trias i Pujol (Badalona)
name: Edgar Castillo-Regalado, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cotton 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.
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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.
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