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Prospective Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 21, 2025; 31(39): 111265
Published online Oct 21, 2025. doi: 10.3748/wjg.v31.i39.111265
Early risk stratification of post-endoscopic retrograde cholangiopancreatography pancreatitis using 4-hour serum amylase and lipase: A prospective study
Jang Han Jung, Kyong Joo Lee, Se Woo Park, Da Hae Park, Hye Won Cha, Dong Hee Koh, Jin Lee
Jang Han Jung, Kyong Joo Lee, Se Woo Park, Da Hae Park, Hye Won Cha, Dong Hee Koh, Jin Lee, Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong 18450, Gyeonggi, South Korea
Co-first authors: Jang Han Jung and Kyong Joo Lee.
Author contributions: Jung JH, Lee KJ, and Park SW wrote the manuscript; Jung JH, Lee KJ, Park SW, Park DH, Cha HW, Koh DH, and Lee J analyzed and interpreted the data; Park SW designed the study, collected the data, and performed the statistical analysis. All authors approved the final manuscript.
Supported by National Research Foundation of Korea, No. NFR-2022R1C1C1006242; and the Hallym University Medical Center Research Fund.
Institutional review board statement: The study adhered to the ethical guidelines of the Declaration of Helsinki and was approved by the Institutional Review Board of Hallym University Dongtan Sacred Hospital (Approval No. 2020-10-001-001).
Clinical trial registration statement: This trial was registered in the International Clinical Trials Registry Platform (https://cris.nih.go.kr) under registration No. KCT0005950.
Informed consent statement: Informed consent was obtained from all patients prior to the procedure.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The data that support the findings of this study are not publicly available, as they are proprietary to the corresponding author; however, detailed summaries and analyses are provided within the article and its Supplementary materials.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Se Woo Park, MD, PhD, Professor, Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7 Keunjaebong-gil, Hwaseong 18450, Gyeonggi, South Korea. mdsewoopark@gmail.com
Received: June 27, 2025
Revised: July 18, 2025
Accepted: September 11, 2025
Published online: October 21, 2025
Processing time: 117 Days and 7.4 Hours
Abstract
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.

Keywords: Pancreatitis; Endoscopic retrograde cholangiopancreatography; Early prediction; Serum biomarker; Hydration

Core Tip: Early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is crucial for timely intervention and reducing adverse outcomes. This large-scale prospective cohort study evaluated the predictive value of 4-hour post-endoscopic retrograde cholangiopancreatography serum amylase and lipase levels in patients with naïve major papillae. The findings demonstrated excellent diagnostic performance, with optimal cut-off values of 1.2 × and 8 × the upper normal limits for amylase and lipase, respectively. These early biomarkers showed high negative predictive values and were effective in identifying patients at risk of developing moderate to severe PEP. Incorporating 4-hour enzyme measurements into clinical practice may significantly improve risk stratification and enable earlier management of PEP.