Abstract
Objectives
Pancreatitis is the most common complication of post-endoscopic retrograde cholangiopancreatography (ERCP). There are currently no prediction models, particularly for post-ERCP pancreatitis (PEP) after biliary stent placement due to malignant biliary obstruction (MBO). To that end, we aim to develop and validate a predictive model for PEP.
Methods
We retrospectively analyzed the data of patients who underwent ERCP for biliary stent placement due to MBO at the Second Affiliated Hospital of Harbin Medical University from January 1, 2014 to August 31, 2021. The eligible patients were randomly allocated to the development and validation cohorts. A prediction model was built using the development cohort, and the model's effect was validated using a validation cohort.
Results
A total of 1524 patients were enrolled, including 1016 in the development cohort and 508 in the validation cohort, with an overall PEP rate of 7.1%. The model’s predictors included acute pancreatitis history, the absence of pancreatic duct dilation, nonpancreatic cancer, difficult cannulation, and pancreatic injection. The area under the curve (AUC) in the development cohort was 0.810, and the incidence of PEP in the low-risk, medium-risk, and high-risk groups was 1.53%, 9.12%, and 36.36%, respectively. Meanwhile, the AUC of the validation cohort was 0.781, and the incidence of PEP in the low-risk, medium-risk, and high-risk groups was 4.17%, 8.75%, and 41.67%, respectively.
Conclusions
This study was the first to build and validate a risk prediction model, especially for PEP after biliary stent placement due to MBO. Moreover, this model might assist clinicians in identifying high-risk patients and help implement preventive measures in a more timely manner.
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References
Boulay BR, Birg A. Malignant biliary obstruction: From palliation to treatment[J]. World J Gastrointest Oncol 2016;8:498–508.
Strasberg SM, Gao F, Sanford D, Linehan DC, Hawkins WG, Fields R, Carpenter DH, Brunt EM, Phillips C. Jaundice: an important, poorly recognized risk factor for diminished survival in patients with adenocarcinoma of the head of the pancreas[J]. HPB (Oxford) 2014;16:150–156.
Dumonceau J-M, Tringali A, Papanikolaou IS, Blero D, Mangiavillano B, Schmidt A, Vanbiervliet G, Costamagna G, Devière J, García-Cano J, Gyökeres T, Hassan C, Prat F, Siersema PD, Van Hooft JE. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017[J]. Endoscopy 2018;50:910–930.
Coté GA, Kumar N, Ansstas M, Edmundowicz SA, Jonnalagadda S, Mullady DK, Azar RR. Risk of post-ERCP pancreatitis with placement of self-expandable metallic stents[J]. Gastrointest Endosc. 2010;72:748–754.
Nam HS, Kang DH, Kim HW, Choi CW, Park SB, Kim SJ, Ryu DG. Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction[J]. World J Gastroenterol. 2017;23:1627–1636.
Kato S, Kuwatani M, Hayashi T, Eto K, Ono M, Ehira N, Yamato H, Sano I, Taya Y, Onodera M, Kubo K, Ihara H, Yamazaki H, Sakamoto N. Inutility of endoscopic sphincterotomy to prevent pancreatitis after biliary metal stent placement in the patients without pancreatic duct obstruction[J]. Scand J Gastroenterol. 2020;55:503–508.
Kullman E, Frozanpor F, Söderlund C, Linder S, Sandström P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck CE, Teder K, Ringman A, Persson G, Gözen M, Eriksson O. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study[J]. Gastrointest Endosc. 2010;72:915–923.
Simoes PK, Schattner MA, Gerdes H, Shah PM, Kurtz RC, Mendelsohn RB. Endoscopic stenting for malignant biliary obstruction is technically successful in patients with preexisting duodenal stents[J]. Endosc Int Open. 2022;10:E429–E433.
Zhou C, Wei B, Wang J, Huang Q, Li H, Gao K. Self-expanding metallic stent fracture in the treatment of malignant biliary obstruction[J]. Gastroenterol Res Pract. 2018;2018:6527879.
Kahaleh M, Talreja JP, Loren DE, Kowalski TE, Poneros JM, Degaetani M, Raijman I, Sejpal DV, Patel S, Rosenkranz L, McNamara KN, Brijbassie A, Wang AY, Gaidhane M, Sethi A, Stevens PD. Evaluation of a fully covered self-expanding metal stent with flared ends in malignant biliary obstruction: a multicenter study[J]. J Clin Gastroenterol. 2013;47:e96–e100.
Siddiqui AA, Mehendiratta V, Loren D, Kowalski T, Fang J, Hilden K, Adler DG. Self-expanding metal stents (SEMS) for preoperative biliary decompression in patients with resectable and borderline-resectable pancreatic cancer: outcomes in 241 patients[J]. Dig Dis Sci. 2013;58:1744–1750.
Shanmugarajah I, Solhaug M, Aslam O, Reiertsen O. Efficacy and safety assessment of ERCP in patients with malignant biliary obstruction[J]. Acta Gastroenterol Belg. 2017;80:487–491.
Guardado NV, Llorente K, Blondeau B. Evaluation and management of malignant biliary obstruction[J]. Surg Oncol Clin N Am. 2021;30:491–503.
Kapoor BS, Mauri G, Lorenz JM. Management of biliary strictures: state-of-the-art review[J]. Radiology. 2018;289:590–603.
Ma MX, Jayasekeran V, Chong AK. Benign biliary strictures: prevalence, impact, and management strategies[J]. Clin Exp Gastroenterol. 2019;12:83–92.
Pereira SP, Goodchild G, Webster GJM. The endoscopist and malignant and non-malignant biliary obstruction[J]. Biochim Biophys Acta Mol Basis Dis. 2018;1864:1478–1483.
Dumonceau J-M, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, Van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline[J]. Endoscopy 2020;52:127–149.
Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, Dewitt JM. Adverse events associated with ERCP[J]. Gastrointest Endosc 2017;85:32–47.
Freeman ML, Disario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study[J]. Gastrointest Endosc 2001;54:425–434.
Zheng R, Chen M, Wang X, Li B, He T, Wang L, Xu G, Yao Y, Cao J, Shen Y, Wang Y, Zhu H, Zhang B, Wu H, Zou X, He G. Development and validation of a risk prediction model and scoring system for post-endoscopic retrograde cholangiopancreatography pancreatitis[J]. Ann Transl Med 2020;8:1299.
Chiba M, Kato M, Kinoshita Y, Shimamoto N, Tomita Y, Abe T, Kanazawa K, Tsukinaga S, Nakano M, Torisu Y, Toyoizumi H, Sumiyama K. The milestone for preventing post-ERCP pancreatitis using novel simplified predictive scoring system: a propensity score analysis[J]. Surg Endosc 2021;35:6696–6707.
Park CH, Park SW, Yang MJ, Moon SH, Park DH. Pre- and post-procedure risk prediction models for post-endoscopic retrograde cholangiopancreatography pancreatitis[J]. Surg Endosc 2022;36:2052–2061.
Fujita K, Yazumi S, Uza N, Kurita A, Asada M, Kodama Y, Goto M, Katayama T, Anami T, Watanabe A, Sugahara A, Mukai H, Kawamura T. New practical scoring system to predict post-endoscopic retrograde cholangiopancreatography pancreatitis: Development and validation[J]. JGH Open 2021;5:1078–1084.
Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus[J]. Gastrointest Endosc 1991;37:383–393.
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS. Classification of acute pancreatitis–2012: revision of the Atlanta classification and definitions by international consensus[J]. Gut 2013;62:102–111.
Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Giménez ME, de Santibañes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos)[J]. J Hepatobiliary Pancreat Sci. 2018;25:41–54.
Young J, Badgery-Parker T, Dobbins T, Jorgensen M, Gibbs P, Faragher I, Jones I, Currow D. Comparison of ECOG/WHO performance status and ASA score as a measure of functional status[J]. J Pain Symptom Manage. 2015;49:258–264.
Budczies J, Klauschen F, Sinn BV, Győrffy B, Schmitt WD, Darb-Esfahani S, Denkert C. Cutoff Finder: a comprehensive and straightforward Web application enabling rapid biomarker cutoff optimization[J]. PloS One 2012;7:e51862.
Xia M-X, Zhou Y-F, Zhang M, Wang W, Wu J, Wang T-T, Zhang X-F, Hu B. Influence of fully covered metal stenting on the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis: A large multicenter study·[J]. J Gastroenterol Hepatol 2020;35:2256–2263.
Kawakubo K, Isayama H, Nakai Y, Togawa O, Sasahira N, Kogure H, Sasaki T, Matsubara S, Yamamoto N, Hirano K, Tsujino T, Toda N, Tada M, Omata M, Koike K. Risk factors for pancreatitis following transpapillary self-expandable metal stent placement[J]. Surg Endosc 2012;26:771–776.
Shimizu S, Naitoh I, Nakazawa T, Hayashi K, Miyabe K, Kondo H, Yoshida M, Yamashita H, Umemura S, Hori Y, Ohara H, Joh T. Predictive factors for pancreatitis and cholecystitis in endoscopic covered metal stenting for distal malignant biliary obstruction[J]. J Gastroenterol Hepatol 2013;28:68–72.
Maruyama H, Shiba M, Ishikawa-Kakiya Y, Kato K, Ominami M, Fukunaga S, Otani K, Hosomi S, Tanaka F, Kamata N, Taira K, Nagami Y, Yamagami H, Tanigawa T, Watanabe T, Yamamoto A, Kabata D, Shintani A, Fujiwara Y. Positive correlation between pancreatic volume and post-endoscopic retrograde cholangiopancreatography pancreatitis[J]. J Gastroenterol Hepatol 2020;35:769–776.
Umemura M, Shimura E, Asai Y, Tsuji A, Nishino M, Takahashi Y, Sasada Y, Saida Y, Kawata K, Sugimoto K, Yamada T. Dilated main pancreatic duct can be a negative predictor of pancreatitis related to biliary SEMS insertion across the papilla[J]. Scand J Gastroenterol 2021;56:865–869.
Ang TL, Kwek ABE, Lim KBL, Teo EK, Fock KM. An analysis of the efficacy and safety of a strategy of early precut for biliary access during difficult endoscopic retrograde cholangiopancreatography in a general hospital[J]. J Dig Dis 2010;11:306–312.
Simmons DT, Petersen BT, Gostout CJ, Levy MJ, Topazian MD, Baron TH. Risk of pancreatitis following endoscopically placed large-bore plastic biliary stents with and without biliary sphincterotomy for management of postoperative bile leaks[J]. Surg Endosc 2008;22:1459–1463.
Cui P-J, Yao J, Zhao Y-J, Han H-Z, Yang J. Biliary stenting with or without sphincterotomy for malignant biliary obstruction: a meta-analysis[J]. World J Gastroenterol 2014;20:14033–14039.
Tamura T, Ogura T, Takenaka M, Tanioka K, Itonaga M, Yamao K, Kamata K, Hirono S, Okada K-I, Imanishi M, Higuchi K, Yamaue H, Kitano M. Endoscopic sphincterotomy to prevent post-ERCP pancreatitis in patients with biliary neoplasms: a multicenter retrospective cohort study[J]. Endosc Int Open 2020;8:E513–E522.
Sofi AA, Nawras A, Alaradi OH, Alastal Y, Khan MA, Lee WM. Does endoscopic sphincterotomy reduce the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis after biliary stenting? A systematic review and meta-analysis[J]. Dig Endosc 2016;28:394–404.
Verma D, Kapadia A, Adler DG. Pure versus mixed electrosurgical current for endoscopic biliary sphincterotomy: a meta-analysis of adverse outcomes[J]. Gastrointest Endosc 2007;66:283–290.
Shin SH, So H, Cho S, Kim N, Baik GH, Lee SK, Park DH. The number of wire placement in the pancreatic duct and metal biliary stent as risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis[J]. J Gastroenterol Hepatol 2020;35:1201–1207.
Martinez NS, Inamdar S, Firoozan SN, Izard S, Lee C, Benias PC, Trindade AJ, Sejpal DV. Evaluation of post-ERCP pancreatitis after biliary stenting with self-expandable metal stents vs plastic stents in benign and malignant obstructions[J]. Endosc Int Open 2021;9:E888–E894.
Jang DK, Kim J, Yoon SB, Yoon WJ, Kim J-W, Lee TH, Jang J-Y, Paik CN, Lee JK. Palliative endoscopic retrograde biliary drainage for malignant biliary obstruction in Korea: A nationwide assessment[J]. Saudi J Gastroenterol 2021;27:173–177.
Wilcox CM, Phadnis M, Varadarajulu S. Biliary stent placement is associated with post-ERCP pancreatitis[J]. Gastrointest Endosc 2010;72:546–550.
Kullman E, Frozanpor F, Söderlund C, Linder S, Sandström P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck C-E, Teder K, Ringman A, Persson G, Gözen M, Eriksson O. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study[J]. Gastrointest Endosc 2010;72:915–923.
Sofi A, Khan AR, Alastal Y, Nawras A. Su1691 no increase in risk of post-ERCP pancreatitis with the placement of biliary self-expandable metal Stents (SEMS) - a systematic review and meta-analysis[J]. Gastrointest Endosc 2014;79:368.
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Fu, Z., Song, J., Pi, Y. et al. A Risk Prediction Model for Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis After Stent Insertion for Malignant Biliary Obstruction: Development and Validation. Dig Dis Sci 68, 1574–1584 (2023). https://doi.org/10.1007/s10620-022-07649-8
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DOI: https://doi.org/10.1007/s10620-022-07649-8