Endoscopic retrograde cholangiopancreatography (ERCP) is associated with higher rates of adverse events (AEs) than other endoscopic procedures. The European Society of Gastrointestinal Endoscopy (ESGE) and the United European Gastroenterology (UEG) have defined specific ERCP quality performance measures, but prospective national ERCP registries are scarce. The aim of this study was to evaluate compliance with ESGE–UEG quality indicators in the first Spanish ERCP registry and determine incidence, severity and predictors of post-ERCP AEs. 

Prospective, multicenter, nationwide study included consecutive ERCPs performed at 17 Spanish hospitals between October 2024 and October 2025. Demographic, clinical, and technical variables were recorded in a standardized electronic database. All patients underwent telephone follow-up at 7 and 30 days. AEs described by AGREE classification. Descriptive statistics were used to evaluate compliance with quality indicators. Logistic regression analyses were conducted to identify independent risk factors for AEs.

A total of 1241 ERCP procedures were included (mean age 70.4 ± 16 years; 48.9% female). Compliance with quality indicators was high: successful biliary cannulation was achieved in 91.6%, extraction of stones <10 mm in 96.2%, and stent placement for distal biliary obstruction in 100% (142/142). Adequate antibiotic prophylaxis was achieved in 99%.

The overall AE rate was 16.8%, and overall mortality was 1.6%. Independent predictors were age (OR 1.72 per 10 years, 95% CI 1.09–2.72) and chronic kidney disease (CKD) (OR 3.17, 95% CI 1.22–8.20). Sex was not associated with mortality.

Post-ERCP pancreatitis (PEP) occurred in 71 cases (5.7%), with AGREE severity grade I-16.9%, II-59.2%, IIIa-9.9%, IIIb-2.8%, IVa-2.8%, IVb-1.4% and V-7%. In the multivariable model, independent predictors of PEP were papilla regular/classic morphology (OR 1.77, 95% CI 1.00–3.12), difficult cannulation (OR 1.86, 95% CI 1.01–3.45) and partially covered metal stent (OR 5.33, 95% CI 2.57–11.09). Unintentional pancreatic cannulation and NSAID prophylaxis were not independently associated with PEP.  Cholangitis occurred in 51 cases (4.1%). Severity by AGREE was grade I-6%, II-50%, IIIa-28%, IIIb-2%, IVa-2% and V-12%. Independent predictors were primary sclerosing cholangitis (OR 8.54, 95% CI 2.11–34.54), malignant stent dysfunction (OR 4.92, 95% CI 1.73–14.02), placement of a plastic biliary stent (OR 2.01, 95% CI 1.08–3.72) and CKD (OR 2.48, 95% CI 1.17–5.26). Female sex showed a protective effect (OR 0.49, 95% CI 0.27–0.90). Cholangitis in suspected malignant stent dysfunction (n=31), occurred in 16.1%, with a trend toward higher risk in those receiving plastic stents (37.5% vs. 8.7%). Bleeding occurred in 60 cases (4.8%). Severity was AGREE I-23%, II-18.3%, IIIa-45%, IV-3.3% and V-5%. Neither antiplatelet nor anticoagulant therapy, comorbidity burden, were associated with bleeding. In multivariable analysis, no independent predictors were identified; sphincterotomy showed only a non-significant trend (OR 1.64, p=0.079). Cholecystitis occurred in 12 patients (1.0%), with AGREE II-33%, IIIa-25%, IIIb-33%, IVa-2% and V-8.3%. Biliary stent placement was independently associated with increased risk (OR 3.93, 95% CI 1.00–15.37). Gallbladder opacification (OR 3.68) and partially covered metal stents (OR 4.41) showed strong but non-significant trends. Fully covered stents were not associated with increased risk. Post-ERCP perforation occurred in 11 patients (0.9%): AGREE II-18%, IIIa-27%, IVa-9.1%, V-45%; intraprocedural 36% and delayed 64%.

This Spanish registry demonstrates high compliance with ESGE–UEG performance measures providing robust real-world data on post-ERCP complications. Systematic follow-up enabled comprehensive AE detection, revealing clinically meaningful predictors. These findings highlight the value of national prospective registries in ERCP practice.