Risk factors for complication following ERCP; results of a large-scale, prospective multicenter study

Background and study aims: Analyses of endoscopic retrograde cholangiopancreatography (ERCP) complication are often constrained by the number of endpoints observed. This largescale study aimed to identify the principal risk factors for ERCP complication. Patients and methods: This was a prospective multicenter study of ERCP complications, based in, five English regions. An exploratory univariable analysis of patients' first recorded procedures identified potentially important patientand procedure- related factors. For overall complications and pancreatitis, variables significant in univariable analysis were included in multiple regression. Results: A total of 66 centers collected data on 5:264 ERCPs, performed on 4561 patients. A therapeutic intervention was attempted in 3447/ 4561 (76%) of patients as part of their first recorded ERCP. Following first recorded ERCP, 230 patients (5.0%) suffered >= complication: pancreatitis in 74 (1.6%), cholangitis in 48 (1.0%), hemorrhage in 40 (0.9%), perforation in 20(0.4%), and miscellaneous in 54 (1.2%). Significant factors from multiple regression were included in a multi-level analysis, which incorporated variables measured at the level of the endoscopist and hospital. For overall complication, risk factors (P value, odds ratio [OR], 95% confidence interval [Cl]) were: carmulation attempts > 1 (P=0.094, OR 1.32, 95% Cl 0.95-1.83), precut (P = 0.033, OR 1.55, 95 % Cl 1.04 - 2.32), and suspected sphincter of Oddi dysfunction (P = 0.121, OR 1.97, 95 % Cl 0.84 - 4.64). For pancreatitis, risk factors (P value, OR, and 95% CI) were: cannulation attempts > 1 (P = 0.0001, OR 3.14, 95 % Cl 1.74 - 5.67), female sex (P < 0.001, OR 2.22, 95 % Cl 1.43 - 3.45), age (P < 0.002, OR 1.09 per 5 year decrease, 95 % Cl 1.03 - 1.15), and performance in a district (as opposed to university) hospital (P = 0.034, OR 2.41, 95 % Cl 1.08 - 5.41). Conclusion: Careful patient selection combined with skilled cannulation minimizes complications. Higher-risk proceduresshould be performed in specialist centers.