A comparison of novel electrocautery-enhanced lumen-apposing metal stents and plastic stents in endoscopic ultrasound-guided drainage of infected walled-off necrosis: a multicenter randomized study

Abstract

Background Although lumen-apposing metal stents (LAMSs) have been increasingly used for walled-off necrosis (WON), their advantages over plastic stents in infected WON are unclear. We investigated the safety and efficacy of a novel electrocautery-enhanced LAMS for managing infected WON.

Methods Patients who required endoscopic ultrasound-guided WON drainage were randomly assigned to LAMS or plastic stent groups. The primary outcome was total number of direct endoscopic necrosectomy (DEN) procedures required to achieve clinical success. Secondary outcomes included rates of technical success, clinical success, and adverse events.

Results 46 patients were included in the LAMS (n = 23) and plastic stent (n = 23) groups. The median total number of DEN procedures did not differ significantly between the plastic stent group (4 procedures, interquartile range [IQR] 2.5–5.0) and LAMS group (9 procedures, IQR 8.0–9.0) (P = 0.07). The LAMS group demonstrated a significantly higher clinical success rate than the plastic stent group based on intention-to-treat analysis (100% vs. 73.9%, P =0.03) at 8 weeks but not at 4 weeks. Significant bleeding occurred in one patient in the plastic stent group and no patients in the LAMS group.

Conclusions We found no significant difference in the total number of DEN procedures between LAMSs and plastic stents for managing infected WON. The only statistically significant finding was a higher clinical success rate at 8 weeks for patients treated with LAMS. The use of LAMS did not result in any adverse events, such as bleeding or buried LAMS syndrome, within the study duration.

Publikationsverlauf

Eingereicht: 24. Dezember 2023

Angenommen nach Revision: 07. Juni 2024

Accepted Manuscript online:
10. Juni 2024

Artikel online veröffentlicht:
07. August 2024

• References

• 1 Siddiqui AA, Kowalski TE, Loren DE. et al. Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success. Gastrointest Endosc 2017; 85: 758-765
• 2 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: 150-157
• 3 Varadarajulu S, Bang JY, Phadnis MA. et al. Endoscopic transmural drainage of peripancreatic fluid collections: outcomes and predictors of treatment success in 211 consecutive patients. J Gastrointest Surg 2011; 15: 2080-2088
• 4 Baron TH, Harewood GC, Morgan DE. et al. Outcome differences after endoscopic drainage of pancreatic necrosis, acute pancreatic pseudocysts, and chronic pancreatic pseudocysts. Gastrointest Endosc 2002; 56: 7-17
• 5 Penn DE, Draganov PV, Wagh MS. et al. Prospective evaluation of the use of fully covered self-expanding metal stents for EUS-guided transmural drainage of pancreatic pseudocysts. Gastrointest Endosc 2012; 76: 679-684
• 6 Shah RJ, Shah JN, Waxman I. et al. Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents. Clin Gastroenterol Hepatol 2015; 13: 747-752
• 7 Siddiqui AA, Adler DG, Nieto J. et al. EUS-guided drainage of peripancreatic fluid collections and necrosis by using a novel lumen-apposing stent: a large retrospective, multicenter U.S. experience (with videos). Gastrointest Endosc 2016; 83: 699-707
• 8 Itoi T, Binmoeller KF, Shah J. et al. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc 2012; 75: 870-876
• 9 Sharaiha RZ, Tyberg A, Khashab MA. et al. Endoscopic therapy with lumen-apposing metal stents is safe and effective for patients with pancreatic walled-off necrosis. Clin Gastroenterol Hepatol 2016; 14: 1797-1803
• 10 Yoo J, Yan L, Hasan R. et al. Feasibility, safety, and outcomes of a single-step endoscopic ultrasonography-guided drainage of pancreatic fluid collections without fluoroscopy using a novel electrocautery-enhanced lumen-apposing, self-expanding metal stent. Endosc Ultrasound 2017; 6: 131-135
• 11 Rinninella E, Kunda R, Dollhopf M. et al. EUS-guided drainage of pancreatic fluid collections using a novel lumen-apposing metal stent on an electrocautery-enhanced delivery system: a large retrospective study (with video). Gastrointest Endosc 2015; 82: 1039-1046
• 12 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: 1200-1209
• 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: 102-111
• 14 Zhang H, Chen GY, Xiao L. et al. Ultrasonic/CT image fusion guidance facilitating percutaneous catheter drainage in treatment of acute pancreatitis complicated with infected walled-off necrosis. Pancreatology 2018; 18: 635-641
• 15 Park CH, Park SW, Hyun B. et al. Efficacy and safety of etomidate-based sedation compared with propofol-based sedation during ERCP in low-risk patients: a double-blind, randomized, noninferiority trial. Gastrointest Endosc 2018; 87: 174-184
• 16 Schulz KF, Altman DG, Moher D. for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Medicine 2010; 8: 18
• 17 Irisawa A, Hikichi T, Bhutani MS. et al. Basic technique of FNA. Gastrointest Endosc 2009; 69 (02) S125-129
• 18 Rerknimitr R. Endoscopic transmural necrosectomy: timing, indications, and methods. Clin Endosc 2020; 53: 49-53
• 19 Chandrasekhara V, Elhanafi S, Storm AC. et al. Predicting the need for step-up therapy after EUS-guided drainage of pancreatic fluid collections with lumen-apposing metal stents. Clin Gastroenterol Hepatol 2021; 19: 2192-2198
• 20 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: 524-546
• 21 Seifert H, Biermer M, Schmitt W. et al. Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study). Gut 2009; 58: 1260-1266
• 22 Abu Dayyeh BK, Mukewar S, Majumder S. et al. Large-caliber metal stents versus plastic stents for the management of pancreatic walled-off necrosis. Gastrointest Endosc 2018; 87: 141-149
• 23 Nass KJ, Zwager LW, van der Vlugt M. et al. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc 2022; 95: 1078-1085.e8
• 24 de Jong DM, Stassen PMC, Schoots IG. et al. Impact of long-term transmural plastic stents on recurrence after endoscopic treatment of walled-off pancreatic necrosis. Endoscopy 2024; 2024
• 25 Bapaye A, Dubale NA, Sheth KA. et al. Endoscopic ultrasonography-guided transmural drainage of walled-off pancreatic necrosis: comparison between a specially designed fully covered bi-flanged metal stent and multiple plastic stents. Dig Endosc 2017; 29: 104-110
• 26 Sharaiha RZ, DeFilippis EM, Kedia P. et al. Metal versus plastic for pancreatic pseudocyst drainage: clinical outcomes and success. Gastrointest Endosc 2015; 82: 822-827
• 27 Bang JY, Hasan MK, Navaneethan U. et al. Lumen-apposing metal stents for drainage of pancreatic fluid collections: when and for whom?. Dig Endosc 2017; 29: 83-90
• 28 Gardner TB, Coelho-Prabhu N, Gordon SR. et al. Direct endoscopic necrosectomy for the treatment of walled-off pancreatic necrosis: results from a multicenter U.S. series. Gastrointest Endosc 2011; 73: 718-726
• 29 Lee KJ, Park SW, Park DH. et al. Placement of plastic stents after direct endoscopic necrosectomy through a novel lumen-apposing metal stent for effective treatment of laterally extended walled-off necrosis: a pilot study. J Clin Med 2023; 12: 1125