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DOI: 10.1055/a-2777-9199
Adherence to ESGE guidelines on biliary stenting in malignant distal strictures: Results from a prospective Italian registry
Authors
Clinical Trial:
Registration number (trial ID): NCT05761496, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Prospective study
Abstract
Background and study aims
Distal malignant biliary strictures (dMBSs) are a common indication for endoscopic retrograde cholangiopancreatography (ERCP). The present study aimed to evaluate adherence of Italian endoscopic centers to European Society of Gastrointestinal Endoscopy (ESGE) guidelines on management of dMBS.
Patients and methods
This prospective cohort, observational, multicenter study was promoted by the Italian Society of Digestive Endoscopy. All consecutive patients with dMBS were included in the registry. Clinical and technical data were recorded. Clinical follow-up was performed at 7 and 30 days, and then every 3 months. Adherence to the eight ESGE recommendations (defined as full-, intermediate- and poor-adherence if > 85%, ≥ 65% to ≤85%, and < 65%, respectively) was considered the primary outcome.
Results
Seventeen Italian endoscopy centers were included. Between January 2020 and January 2022, 827 patients were included. Full adherence to the guidelines was reported for post-ERCP acute pancreatitis prophylaxis, retreatments, and preoperative biliary drainage. Intermediate adherence was reported for type of stent used in palliative drainage (85% SEMS and 15% plastic stents). Poor adherence was reported for type of stent used in preoperative drainage (56% self-expandable metal stents [SEMSs]), availability of pathological diagnosis in case of U-SEMS placement (45% of U-SEMSs placed without pathologically diagnosis), antibiotic prophylaxis (70.6%), and sphincterotomy (88%).
Conclusions
Adherence to ESGE guidelines needs to be improved in specific areas, including excessive use of plastic stents, use of U-SEMS without pathological diagnosis, and routine performance of sphincterotomy and use of antibiotic prophylaxis. (ClinicalTrials.gov ID: NCT05761496)
Publication History
Received: 31 March 2025
Accepted after revision: 17 November 2025
Accepted Manuscript online:
22 December 2025
Article published online:
26 January 2026
© 2026. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).
Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Tommaso Schepis, Rocco Maurizio Zagari, Stefano Francesco Crinó, Marco Sacco, Enrico Palmeri, Roberto Grassia, Alessio Santagati, Giovanna Venezia, Nicola Olivari, Alba Panarese, Massimiliano Mutignani, Ivano Biviano, Helga Bertani, Massimo Devani, Samuele de Minicis, Giuseppe de Roberto, Antonio Aucello, Socrate Pallio, Armando Gabbrielli, Sebastian Manuel Milluzzo, Maria Caterina Parodi, Luigi Pasquale, Guido Costamagna, Elton Dajti, Andrea Tringali. Adherence to ESGE guidelines on biliary stenting in malignant distal strictures: Results from a prospective Italian registry. Endosc Int Open 2026; 14: a27779199.
DOI: 10.1055/a-2777-9199
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References
- 1 Xia M, Qin W, Hu B. Endobiliary radiofrequency ablation for unresectable malignant biliary strictures: Survival benefit perspective. Digest Endosc 2023; 35: 584-591
- 2 Sung H, Ferlay J, Siegel RL. et al. Global cancer statistics 2020: Globocan estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2021; 71: 209-249
- 3 Ferlay J, Partensky C, Bray F. More deaths from pancreatic cancer than breast cancer in the EU by 2017. Acta Oncol 2016; 55: 1158-1160
- 4 Nehme F, Lee JH. Preoperative biliary drainage for pancreatic cancer. Digest Endosc 2022; 34: 428-438
- 5 Costamagna G, Tringali A, Perri V. et al. Endotherapy of postcholecystectomy biliary strictures with multiple plastic stents: Long-Term results in a large cohort of patients. Gastrointest Endosc 2019; 91: 81-89
- 6 Lawrence C, Romagnuolo J, Payne KM. et al. Low symptomatic premature stent occlusion of multiple plastic stents for benign biliary strictures: Comparing standard and prolonged stent change intervals. Gastrointest Endosc 2010; 72: 558-563
- 7 Kwon C Il, Lehman GA. Mechanisms of biliary plastic stent occlusion and efforts at prevention. Clin Endosc 2016; 49: 139-146
- 8 Isayama H, Nakai Y, Kogure H. et al. Biliary self-expandable metallic stent for unresectable malignant distal biliary obstruction: Which is better: Covered or uncovered?. Digest Endosc 2013; 25: 71-74
- 9 Gómez-Oliva C, Guarner-Argente C, Concepción M. et al. Partially covered self-expanding metal stent for unresectable malignant extrahepatic biliary obstruction: Results of a large prospective series. Surg Endosc 2012; 26: 222-229
- 10 Jain D, Stein A, Hasan MK. Stepwise algorithmic approach to endoscopic removal of biliary partially covered and uncovered self-expanding metal stents (with Videos). Clin Endosc 2021; 54: 608-612
- 11 Sawas T, Al Halabi S, Parsi MA. et al. Self-expandable metal stents versus plastic stents for malignant biliary obstruction: A meta-analysis. Gastrointest Endosc 2015; 82: 256-267.e7
- 12 Tamura T, Yamai T, Uza N. et al. Adverse events of self-expandable metal stent placement for malignant distal biliary obstruction: A large multicenter study. Gastrointest Endosc 2023; 99: 61-72.e8
- 13 Dumonceau J-M, Tringali A, Papanikolaou I. et al. Endoscopic biliary stenting: Indications, choice of stents, and results: European society of gastrointestinal endoscopy (ESGE) clinical guideline-updated october 2017. Endoscopy 2017; 50: 910-930
- 14 Crippa S, Cirocchi R, Partelli S. et al. Systematic review and meta-analysis of metal versus plastic stents for preoperative biliary drainage in resectable periampullary or pancreatic head tumors. Eur J Surg Oncol 2016; 42: 1278-1285
- 15 Cavell LK, Allen PJ, Vinoya C. et al. Biliary self-expandable metal stents do not adversely affect pancreaticoduodenectomy. Am J Gastroenterol 2013; 108: 1168-1173
- 16 Moole H, Bechtold ML, Cashman M. et al. Covered versus uncovered self-expandable metal stents for malignant biliary strictures: A meta-analysis and systematic review. Indian J Gastroenterol 2016; 35: 323-330
- 17 Martins OC, Antunes V, Florêncio De Mesquita C. et al. The addition of endoscopic sphincterotomy to biliary stent placement and its impact on the risk of adverse events: An updated meta-analysis of randomized controlled trials. Gastrointest Endosc 2024; 100: 406-414.e2
- 18 Ahn J, Ahn D-W, Park J. et al. Association between progression-free survival and metal stent patency in patients with advanced pancreatic cancer. J Gastrointest Oncol 2022; 13: 1981-1988
- 19 Domagk D, Poremba C, Dietl K-H. et al. Endoscopic transpapillary biopsies and intraductal ultrasonography in the diagnostics of bile duct strictures: A prospective study. Gut 2002; 51: 240-244
- 20 Dumonceau J-M, Kapral C, Aabakken L. et al. ERCP-related adverse events: European society of gastrointestinal endoscopy (ESGE) guideline. Endoscopy 2019; 52: 127-149
- 21 Inamdar S, Slattery E, Bhalla R. et al. Comparison of adverse events for endoscopic vs percutaneous biliary drainage in the treatment of malignant biliary tract obstruction in an inpatient national cohort. JAMA Oncol 2016; 2: 112
- 22 Han SY, Kim S-O, So H. et al. EUS-guided biliary drainage versus ERCP for first-line palliation of malignant distal biliary obstruction: A systematic review and meta-analysis. Sci Rep 2019; 9
- 23 Sharaiha RZ, Khan MA, Kamal F. et al. Efficacy and safety of eus-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: A systematic review and meta-analysis. Gastrointest Endosc 2017; 85: 904-914
- 24 Tanaka M, Fernández-Del Castillo C, Adsay V. et al. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology 2012; 12: 183-197
- 25 Lam R, Muniraj T. Fully covered metal biliary stents: A review of the literature. World J Gastroenterol 2021; 27: 6357-6373
- 26 Wolfson D, Barkin JS, Chari ST. et al. Management of pancreatic masses. Pancreas 2005; 31: 203-217
- 27 Vernuccio F, Borhani AA, Dioguardi Burgio M. et al. Common and uncommon pitfalls in pancreatic imaging: It is not always cancer. Abdom Radiol 2016; 41: 283-294
- 28 Jain D, Stein A, Hasan MK. Stepwise algorithmic approach to endoscopic removal of biliary partially covered and uncovered self-expanding metal stents (with Videos). Clin Endosc 2021; 54: 608-612
- 29 Krishnamoorthi R, Jayaraj M, Kozarek R. Endoscopic stents for the biliary tree and pancreas. Curr Treat Options Gastroenterol 2017; 15: 397-415
- 30 Park JK, Moon JH, Choi HJ. et al. Anchoring of a fully covered self-expandable metal stent with a 5F double-pigtail plastic stent to prevent migration in the management of benign biliary strictures. Am J Gastroenterol 2011; 106: 1761-1765
- 31 Park DH, Lee SS, Lee TH. et al. Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: A multicenter, prospective, comparative pilot study (with videos). Gastrointest Endosc 2011; 73: 64-70
- 32 Buxbaum JL, Freeman M, Amateau SK. et al. American Society for Gastrointestinal Endoscopy guideline on post-ercp pancreatitis prevention strategies: Methodology and review of evidence. Gastrointest Endosc 2023; 97: 163-183.e40
- 33 Buxbaum JL, Freeman M, Amateau SK. et al. American society for gastrointestinal endoscopy guideline on post-ercp pancreatitis prevention strategies: Summary and recommendations. Gastrointest Endosc 2023; 97: 153-162
- 34 Cui P-JJ, Yao J, Zhao YJ. et al. Biliary stenting with or without sphincterotomy for malignant biliary obstruction: A meta-analysis. World J Gastroentero 2014; 20: 14033
- 35 Sofi AA, Nawras A, Alaradi OH. et al. Does endoscopic sphincterotomy reduce the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis after biliary stenting? A systematic review and meta-analysis. Digest Endosc 2016; 28: 394-404
