A Clinical Scoring Model to Predict Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis in Biliary Endoscopic Retrograde Cholangiopancreatography for Patients With Intact Papilla: A Large Multicenter Prospective Cohort Study.

Objectives: The risk of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) needs to be predicted in order to take adequate preventive measures in individual cases. The aim of this study was to develop a clinical prediction rule for PEP in biliary ERCP for patients with intact papilla. Methods: We conducted a multicenter prospective cohort study to investigate the adverse events of biliary ERCP in patients with intact papilla. A total of 3739 patients were prospectively enrolled at 36 hospitals in western Japan between April 2017 and March 2018. Data on patient-related factors, operator-related factors, procedure-related factors, and preventative measures were collected. A multivariable logistic regression was used to identify predictors for PEP, and a scoring model was developed. Results: The scoring model included 11 factors: age younger than 50 years (2 points), female sex (1 point), ASA 3 (-2 points), cholangitis (-1 point), hypoamylasemia (-1 point), obstruction of the main pancreatic duct at the pancreatic head (-2 points), cannulation time >20 min (1 point), guidewire insertion into the pancreatic duct (3 points), intraductal ultrasonography (1 point), biopsy (1 point), and total procedure time >60 min (2 points). The area under the receiver operating characteristic curve of this model was 0.729. All cases were stratified into three groups according to the total score: low-risk, intermediate-risk, and high-risk groups, with an incidence of PEP of 1.6%, 6.0%, and 17.7%, respectively. Conclusions: This scoring model stratified the risk of PEP in individual ERCP cases with intact papilla fairly well.