In this study, adverse events (AEs) incidence was 10.1% in patients with intact papilla who underwent biliary endoscopic retrograde cholangiopancreatography (ERCP). Mortality was 0.08%, and post-ERCP pancreatitis (PEP) may be avoided by prophylactic pancreatic stenting (PPS) and epinephrine spraying.

• This study included 16,032 ERCP procedures in 3,739 patients to assess the incidence and severity of AEs in biliary ERCP as well as to specify the risk factors and preventive measures for PEP.

• The overall incidence of AEs was estimated to be 10.1% and ERCP-associated mortality was 0.08%.

• PEP, bleeding, instrumental AEs, infections, cardiovascular AEs, pulmonary AEs, drug reaction AE, pain, and other AEs occurred in 6.9%, 0.9%, 0.5%, 1.0%, 0.2%, 0.2%, 0.03%, 0.4%, and 0.4% of cases respectively.

• Female of younger age, pancreatic guidewire-assisted biliary cannulation, temporary guidewire insertion into the pancreatic duct, total procedure time >60 min, and post-ERCP use of non-steroidal anti-inflammatory drugs were the significant risk factors for PEP.

• PPS and epinephrine spraying onto the papilla were effective as preventive measures.