Lumen apposing metal stents for the treatment of pancreatic and peri-pancreatic fluid collection and bleeding risk: a propensity matched study

Aims Endoscopic ultrasound (EUS)-guided drainage with luminal apposing metal stent (LAMS) has become the treatment of choice of symptomatic pancreatic fluid collections (PFCs). Recent studies reported a not negligible bleeding risk after Axios stent placement. Spaxus stent has blunt extremity and a softer design. Our aim was to compare the risk of bleeding between the two stents. (▶[Table 1] [2] [3] [4] [5] [6] [7] [8] [8]).

Table 1 Characteristics of the Axios/Hot-Axios (a) and Spaxus/Hot-Spaxus (b) utilized for drainage of pancreatic fluid collection.

Table 2 Baseline characteristics of the 363 patients who were treated with Hot-Axios and both Cold and Hot-Spaxus who were retrospectively retrieved from database of 18 centers.

Table 3 Overall patient's and procedures features.

Table 4 Baseline characteristics of 324 patients who were selected after 1-to-1 propensity score matching,

Table 5 Outcomes of EUS-guided Pancreatic fluid collection drainage with divided based on the stent utilized.

Table 6 Outcomes of the enrolled patients regarding relating to LAMS type and diameter.

Fig. 7Logistic regression analysis for severe bleeding rate.

Fig. 8

Fig. 8

Methods This is a retrospective study in patients with PFC and treated by Axios and Spaxus (both cold and hot), in eighteen endoscopic referral centers [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23] [24] [25] [26] [27].

Results 363 patients were included in the study. The most common type of collection was WON (60% Spaxus group vs 70% Axios; p=0.12). Median size of the collection was 9.65 cm (7-12.57) in the Spaxus and 10 cm (7-13.8) in the Axios group (p=0.50). After 1-to-1 propensity score match, 324 patients were selected (162 per group). Technical success was 100% with Spaxus and 98% with Axios (p=0.10). Adverse events (AEs) were observed in 4 patients treated with Spaxus (2.4%): 2 patients experienced severe bleeding (1.2%); 18 patients experienced AEs with Axios (11.1%): 10 cases of severe bleeding (6.1%) and 1 moderate (0.6%). The difference between the two groups in terms of both AE rate and severe bleeding rate was significant (p=0.001 and p=0.01, respectively).

Conclusions Bleeding is a not negligible AE after PFC drainage by LAMS and is more than five times with Axios, as compared to Spaxus stent. Spaxus stent results the stent of choice over Axios for the EUS-guided PFC drainage with LAMS.

Publication History

Article published online:
14 April 2023

• 1 Li J, Zhang Q, Zhou A. et al. Comparative outcomes of endoscopic ultrasound-guided lumen-apposing mental stents drainage for pancreatic pseudocysts and walled-off necrosis: Case series and meta-analysis. Chronic Dis Transl Med 2021; 7: 157-68
• 2 Teoh AYB, Bapaye A, Lakhtakia S. et al. Prospective multicenter international study on the outcomes of a newly developed self-approximating lumen-apposing metallic stent for drainage of pancreatic fluid collections and endoscopic necrosectomy. Dig Endosc 2020; 32: 391-8
• 3 Fugazza A, Sethi A, Trindade AJ. et al. International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage. Gastrointest Endosc 2020; 91: 574-83
• 4 Yang D, Perbtani YB, Mramba LK. et al. Safety and rate of delayed adverse events with lumen-apposing metal stents (LAMS) for pancreatic fluid collections: a multicenter study. Endosc Int Open 2018; 6: E1267-75
• 5 Adler DG, Taylor LJ, Hasan R. et al. A retrospective study evaluating endoscopic ultrasound-guided drainage of pancreatic fluid collections using a novel lumen-apposing metal stent on an electrocautery enhanced delivery system. Endosc Ultrasound 2017; 6: 389-93
• 6 Onnekink AM, Boxhoorn L, Timmerhuis HC. et al. Endoscopic Versus Surgical Step-Up Approach for Infected Necrotizing Pancreatitis (ExTENSION): Long-term Follow-up of a Randomized Trial. Gastroenterology 2022; 163: 712-22
• 7 Zhai YQ, Ryou M, Thompson CC.. Predicting success of direct endoscopic necrosectomy with lumen-apposing metal stents for pancreatic walled-off necrosis. Gastrointest Endosc 2022; 96: 522-9
• 8 Hammad T, Khan MA, Alastal Y. et al. Efficacy and Safety of Lumen-Apposing Metal Stents in Management of Pancreatic Fluid Collections: Are They Better Than Plastic Stents? A Systematic Review and Meta-Analysis. Dig Dis Sci 2018; 63: 289-301
• 9 Tan S, Zhong C, Ren Y. et al. Are Lumen-Apposing Metal Stents More Effective Than Plastic Stents for the Management of Pancreatic Fluid Collections: An Updated Systematic Review and Meta-analysis. Gastroenterol Res Pract 2020; 2020: 4952721
• 10 Mangiavillano B, Arcidiacono PG, Masci E. et al. Single-step versus two-step endo-ultrasonography-guided drainage of pancreatic pseudocyst. J Dig Dis 2012; 13: 47-5
• 11 Arvanitakis M, Dumonceau JM, Albert J. et al. Endoscopic management of acute necrotizing pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) evidence-based multidisciplinary guidelines. Endoscopy 2018; 50: 524-46
• 12 Dumonceau JM, Delhaye M, Tringali A. et al. Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Updated August 2018. Endoscopy 2019; 51: 179-93
• 13 Banks PA, Bollen TL, Dervenis C. et al. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut 2013; 62: 102-11
• 14 Facciorusso A, Di Maso M, Antonino M. et al. Polidocanol injection decreases the bleeding rate after colon polypectomy: A propensity score analysis. Gastrointest Endosc 2015; 82: 350-8
• 15 Austin PC.. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivar Behav Res 2011; 46: 399-424
• 16 Austin PC.. A critical appraisal of propensity-score matching in the medical literature between 1996 and 2003. Stat Med 2007; 27: 2037-49
• 17 Mangiavillano B, Moon JH, Crinò SF. et al. Safety and efficacy of a novel electrocautery-enhanced lumen-apposing metal stent in interventional EUS procedures (with video). Gastrointest Endosc 2022; 95: 115-22
• 18 Larghi A, Crinò SF, Vanella G, Rizzatti G, Bernardoni L, Arcidiacono PG.. Preliminary experience of EUS-guided pancreatic fluid collections drainage using a new lumen-apposing metal stent mounted on a cautery device. Endosc Ultrasound 2022; 11: 84-5
• 19 Mangiavillano B, Moon JH, Facciorusso A. et al. EUS-guided biliary drainage with a novel electrocautery-enhanced lumen apposing metal stent as first approach for distal malignant biliary obstruction: a prospective study. Endosc Intern Open. 2022 Epub ahead of print
• 20 Jo SJ, Moon JH, Lee YN. et al. A novel bipolar electrocautery-enhanced delivery system with a lumen-apposing metal stent for EUS-guided drainage: A porcine study [published online ahead of print]. J Hepatobiliary Pancreat Sci. 2022
• 21 Rimbaş M, Pizzicanella M, Larghi A.. EUS-guided treatment of WON using lumen-apposing metal stents: protocol standardisation based on the occurrence of natural healing processes. Gut 2019; 68: 1334-5
• 22 Ramai D, Facciorusso A, De Luca M. et al. Adverse events associated with AXIOS stents: Insights from the manufacturer and user facility device experience database. Endosc Ultrasound. 2022 Epub ahead of print
• 23 Lang GD, Fritz C, Bhat T. et al. EUS-guided drainage of peripancreatic fluid collections with lumen-apposing metal stents and plastic double-pigtail stents: comparison of efficacy and adverse event rates. Gastrointest Endosc 2018; 87: 150-7
• 24 Brimhall B, Han S, Tatman PD. et al. Increased Incidence of Pseudoaneurysm Bleeding With Lumen-Apposing Metal Stents Compared to Double-Pigtail Plastic Stents in Patients With Peripancreatic Fluid Collections. Clin Gastroenterol Hepatol 2018; 16: 1521-8
• 25 Bang JY, Navaneethan U, Hasan MK. et al. Non-superiority of lumen-apposing metal stents over plastic stents for drainage of walled-off necrosis in a randomised trial. Gut 2019; 68: 1200-9
• 26 Bang JY, Hasan M, Navaneethan U. et al. Lumen-apposing metal stents (LAMS) for pancreatic fluid collection (PFC) drainage: may not be business as usual. Gut 2017; 66: 2054-6
• 27 Bhakta D, de Latour R, Khanna L.. Management of pancreatic fluid collections. Transl Gastroenterol Hepatol. 2022 In press