Clinical Characteristics, ERCP Management, and Early Adverse Events Among Patients with Choledocholithiasis at a Romanian Tertiary Referral Center: A Retrospective Cohort

Background: Choledocholithiasis is a common cause of biliary obstruction and may lead to acute cholangitis, pancreatitis, and other serious complications. Despite the widespread use of endoscopic retrograde cholangiopancreatography (ERCP), data describing the clinical profile and management of patients with choledocholithiasis in Romania remain limited. Objectives: This study aimed to describe demographic characteristics, diagnostic work-up, procedural characteristics of ERCP, microbiological findings, and early clinical outcomes of patients with choledocholithiasis undergoing ERCP at a high-volume tertiary referral center. Methods: We conducted a retrospective, observational, single-center cohort study of adults with confirmed choledocholithiasis who underwent ERCP between January 2021 and September 2025. During the study period, 2514 ERCP procedures were performed at our center for all indications, of which 631 unique patients with choledocholithiasis fulfilled the eligibility criteria and were included in the final cohort. Demographic characteristics, comorbidities, clinical presentation, laboratory findings, imaging results, ERCP-related variables, and early procedural outcomes were analyzed descriptively. Results: The cohort included 631 patients with a median age of 68 years (IQR 56–77), and 59.9% were women. Abdominal pain (59.3%) and jaundice (48.2%) were the most common presenting symptoms. Acute cholangitis was present in 57.7% of patients; among these patients, severity according to the Tokyo Guidelines 2018 was mild in 52.7%, moderate in 10.7%, and severe in 36.6%. Computed tomography was the most frequent imaging modality confirming the diagnosis (42.5%), followed by magnetic resonance cholangiopancreatography (30.7%) and ultrasonography (26.8%). Median common bile duct diameter was 14 mm and median stone diameter was 7.9 mm; multiple stones or sludge were present in 56.7%. Difficult cannulation occurred in 10.8% of patients, mechanical lithotripsy in 19.5%, biliary stent placement in 18.9%, and post-ERCP pancreatitis in 10.8%. Intraprocedural bleeding occurred in 4.9% of patients, while post-ERCP bleeding occurred in 1.9% and no perforations were recorded. In-hospital mortality occurred in 2 patients (0.3%). Bile cultures were obtained in 52 patients (8.3%), of which 37 (71.2%) yielded bacterial growth, with Escherichia coli being the most frequently isolated microorganism. Conclusions: This study provides real-world evidence on the epidemiology, diagnostic evaluation, ERCP management, and early outcomes of choledocholithiasis in a Romanian tertiary referral center.