Introduction
Post-ERCP pancreatitis (PEP) is the most important adverse event of ERCP. In order to make a decision to take adequate preventive measures, it is necessary to estimate the risk of PEP in individual cases. Several models have been reported to predict PEP, but these models do not have high generalizability.
Aims & Methods
The aim of this study is to develop a reliable prediction rule for PEP in biliary ERCP for patients with intact papilla.
We had conducted a multicenter prospective cohort study which investigated the incidence of adverse events of biliary ERCP in patients with intact papilla (1). This study is a sub-analysis of the cohort study. A total of 3739 patients were prospectively enrolled at 36 hospitals of the Biliopancreatic Study Group of West Japan between April 2017 and March 2018. Exclusion criteria were acute pancreatitis, altered gastrointestinal anatomy, and an ASA physical status greater than 3.
The primary outcomes were the incidence of PEP. The diagnosis and severity of PEP were defined by the lexicon for endoscopic adverse events (2). Patient-related factors, operator-related factors, procedure-related factors and preventative measures were accumulated.
Multivariable logistic regression analysis with stepwise methods were used to identify predictors for PEP and a scoring model was developed based on their β coefficients.
The performance of the model was evaluated based on area under the receiver-operating characteristic curve (AUC), calibration and clinical adequacy. In addition, internal validity was assessed using the bootstrap method by sampling with replacements for 2000 iterations.
Results
PEP developed in 258 cases (6.9%), 201 mild, 39 moderate, 17 severe and 1 fatal. Significant factors with adjusted odds ratios (OR) in multivariate analysis were under 50 years old (OR: 1.78 [95% confidence interval (CI), 1.10-2.79]), female (OR: 1.33 [95% CI, 1.02-1.73]), ASA 3 (OR: 0.62 [95% CI, 0.39-0.95]), cholangitis (OR: 0.72 [95% CI, 0.52-0.98]), hypoamylasemia (OR: 0.62 [95% CI, 0.37-0.97]), obstruction of the main pancreatic duct (MPD) at the pancreatic head (OR: 0.41 [95% CI, 0.22-0.71]), cannulation time > 20 min (OR: 1.43 [95% CI, 1.03-1.97]), guidewire insertion into pancreatic duct (OR: 2.88 [95% CI, 2.17-3.82]), intraductal ultrasonography (IDUS) (OR: 1.49 [95% CI, 1.00-2.17]), biopsy (OR: 1.51 [95% CI, 1.00-2.23]) and total procedure time > 60 min (OR:1.64 [95% CI, 1.17-2.28]).
A scoring system was constructed from the eleven clinical variables as below. Under 50 years old: 2 points, female: 1 point, ASA 3: -2 points, cholangitis: -1 point, hypoamylasemia: -1 point, obstruction of the MPD at the pancreatic head: -2 points, cannulation time > 20 min: 1 point, guidewire insertion into pancreatic duct: 3 points, IDUS: 1 point, biopsy: 1 point and total procedure time > 60 min: 2 points. The points were added up to a total score that predicts the risk of pancreatitis.
AUC of this scoring model was 0.721. A bootstrap analysis revealed a corrected AUC of 0.728 (95%CI: 0.697 - 0.759).
When all cases were divided into three groups; a low-risk group (scoring -1 points or fewer), an intermediate-risk group (between 0 and 3 points) and a high-risk group (more than 4 points), the incidence of PEP were 1.6% (17/1048), 6.0% (121/2012) and 17.7% (120/679), respectively.
Conclusion
This scoring model is useful for predicting and stratifying the risk of PEP in individual cases. Aggressive preventive measures are recommended for patients in the high-risk group with a score of 4 or higher.
References
1. Fujita K, Yazumi S, Matsumoto H, Asada M, Nebiki H, Matsumoto K, et al. 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. Dig Endosc. 2022;34(6):1198-204.
2. Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010;71(3):446-54.