Early risk stratification of post-endoscopic retrograde cholangiopancreatography pancreatitis using 4-hour serum amylase and lipase: A prospective study

BACKGROUND Current diagnostic standards for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) rely on 24-hour post-ERCP amylase and lipase levels, delaying timely intervention and highlighting the need for earlier predictive biomarkers. AIM To evaluate the utility of 4-hour post-ERCP serum amylase and lipase levels in a large cohort to establish optimal cut-off values and improve early PEP prediction. METHODS This prospective study involved patients with naïve major papillae who underwent diagnostic or therapeutic ERCP between June 2021 and December 2024. Serum amylase and lipase levels were measured before ERCP and 4 hours and 24 hours after ERCP. The primary endpoint was to determine optimal cut-off values for 4-hour serum amylase and lipase levels for the early prediction of PEP. RESULTS PEP occurred in 117 patients (6.1%). Diagnostic performance assessment of 4-hour serum amylase and lipase for predicting PEP yielded area under the curves of 0.877 and 0.893, respectively. Optimal cut-off values were 1.2 times the upper normal limit (119.5 IU/L) for amylase and 8 times the upper normal limit (488.5 IU/L) for lipase. At these thresholds, 4-hour amylase demonstrated a sensitivity of 0.846, a specificity of 0.806, and a negative predictive value of 0.988. Similarly, 4-hour lipase showed a sensitivity of 0.863, a specificity of 0.862, and a negative predictive value of 0.990. These biomarkers effectively predicted moderately severe to severe PEP in high-risk groups. CONCLUSION Early measurement of 4-hour serum amylase and lipase shows strong predictive capabilities for PEP, with clinically meaningful cut-off values. These biomarkers enable timely interventions, potentially reducing PEP-related adverse events and the overall healthcare burden.