Multicenter prospective cohort study of adverse events associated with biliary endoscopic retrograde cholangiopancreatography: Incidence of adverse events and preventive measures for post‐endoscopic retrograde cholangiopancreatography pancreatitis

<jats:sec><jats:title>Objectives</jats:title><jats:p>The reported incidence of adverse events (AEs) in endoscopic retrograde cholangiopancreatography (ERCP) varies between 2.5% and 14%. The aim of this study was to evaluate the incidence and severity of AEs in biliary ERCP and to specify the risk factors and preventive measures for post‐ERCP pancreatitis (PEP).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Patients with biliary disease with intact papilla were prospectively enrolled at 36 hospitals between April 2017 and March 2018. The primary outcomes were the incidence and severity of AEs.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 16,032 ERCP procedures were performed at the 36 hospitals during the study period and 3739 patients were enrolled. The overall incidence of AEs was 10.1% and ERCP‐related mortality was 0.08%. PEP developed in 258 cases (6.9%), bleeding in 33 (0.9%), instrumental AEs in 17 (0.5%), infections in 37 (1.0%), cardiovascular AEs in eight (0.2%), pulmonary AEs in eight (0.2%), drug reaction AE in one (0.03%), pain in 15 (0.4%), and other AEs in 15 (0.4%). Multivariable analysis showed significant risk factors for PEP were: female of younger age, pancreatic guidewire‐assisted biliary cannulation, temporary guidewire insertion into the pancreatic duct, total procedure time >60 min, and post‐ERCP administration of non‐steroidal anti‐inflammatory drugs. Effective preventive measures were prophylactic pancreatic stenting (PPS) and epinephrine spraying onto the papilla.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>In patients with intact papilla who underwent biliary ERCP, the incidence of AEs was 10.1% and the mortality was 0.08%. PPS and epinephrine spraying may prevent PEP.</jats:p></jats:sec><jats:sec><jats:title>Registration</jats:title><jats:p>This study was registered in the University Hospital Medical Information Network (UMIN000024820).</jats:p></jats:sec>