Biflanged metal stents versus plastic stents for endoscopic ultrasound-guided drainage of walled-off necrosis: a randomized controlled trial

Abstract

Background Endoscopic ultrasound (EUS)-guided drainage of walled-off necrosis (WON) using either plastic or metal stents is the mainstay of WON management. Our single-center randomized controlled trial aimed to evaluate the efficacy of biflanged metal stents (BFMSs) and plastic stents for WON drainage.

Methods Patients with symptomatic WON amenable to EUS-guided drainage were randomized to receive either BFMSs or plastic stents. The primary outcome was reintervention-free clinical success at 4 weeks. Secondary outcomes were: overall clinical success (complete resolution of symptoms and significant reduction in size of WON [<50% of original size and <5 cm in largest diameter at 4-week follow-up]); number of reinterventions; adverse events (AEs); hospital stay for first admission; and medium-term outcomes at 6 months (recurrence, disconnected pancreatic duct, chronic pancreatitis, and new-onset diabetes mellitus).

Results 92 patients were randomized: 46 in each arm. The reintervention-free clinical success rate was significantly higher in the BFMS group on intention-to-treat analysis (67.4% vs. 43.5%; P = 0.02). Overall clinical success at 1 month was similar in both groups. There were significantly fewer reinterventions (median 0 [IQR 0–1] vs. 1 [0–2]; P = 0.03) and shorter hospital stays in the BFMS group (7.0 [SD 3.4] vs. 9.1 [5.5] days; P = 0.04). There were no differences in procedure-related AEs, mortality, or medium-term outcomes.

Conclusions BFMSs provide better reintervention-free clinical success at 4 weeks, with shorter hospital stay and without increased risks of AEs, compared with plastic stents for EUS-guided drainage of WON. Medium-term outcomes are however similar for both stent types.

Publication History

Received: 16 August 2023

Accepted after revision: 23 May 2024

Accepted Manuscript online:
23 May 2024

Article published online:
30 July 2024

• References

• 1 van Santvoort HC, Besselink MG, Bakker OJ. et al. A step-up approach or open necrosectomy for necrotizing pancreatitis. NEJM 2010; 362: 1491-1502
• 2 Bang JY, Arnoletti JP, Holt BA. et al. An endoscopic transluminal approach, compared with minimally invasive surgery, reduces complications and costs for patients with necrotizing pancreatitis. Gastroenterology 2019; 156: 1027-1040 e1023
• 3 Bakker OJ, van Santvoort HC, van Brunschot S. et al. Endoscopic transgastric vs surgical necrosectomy for infected necrotizing pancreatitis: a randomized trial. JAMA 2012; 307: 1053-1061
• 4 Trikudanathan G, Wolbrink DRJ, van Santvoort HC. et al. Current concepts in severe acute and necrotizing pancreatitis: an evidence-based approach. Gastroenterology 2019; 156: 1994-2007 e1993
• 5 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
• 6 Chen YI, Yang J, Friedland S. et al. Lumen apposing metal stents are superior to plastic stents in pancreatic walled-off necrosis: a large international multicenter study. Endosc Int Open 2019; 7: E347-E354
• 7 Karstensen JG, Novovic S, Hansen EF. et al. EUS-guided drainage of large walled-off pancreatic necroses using plastic versus lumen-apposing metal stents: a single-centre randomised controlled trial. Gut 2023; 72: 1167-1173
• 8 Lakhtakia S, Basha J, Talukdar R. et al. Endoscopic "step-up approach" using a dedicated biflanged metal stent reduces the need for direct necrosectomy in walled-off necrosis (with videos). Gastrointest Endosc 2017; 85: 1243-1252
• 9 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
• 10 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
• 11 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 e1078
• 12 Boxhoorn L, Verdonk RC, Besselink MG. et al. Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis. Gut 2023; 72: 66-72
• 13 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
• 14 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
• 15 Mohan BP, Jayaraj M, Asokkumar R. et al. Lumen apposing metal stents in drainage of pancreatic walled-off necrosis, are they any better than plastic stents? A systematic review and meta-analysis of studies published since the revised Atlanta classification of pancreatic fluid collections. Endosc Ultrasound 2019; 8: 82-90
• 16 Yoon SB, Lee IS, Choi MG. Metal versus plastic stents for drainage of pancreatic fluid collection: A meta-analysis. United European Gastroenterol J 2018; 6: 729-738
• 17 Saunders R, Ramesh J, Cicconi S. et al. A systematic review and meta-analysis of metal versus plastic stents for drainage of pancreatic fluid collections: metal stents are advantageous. Surg Endosc 2019; 33: 1412-1425
• 18 Bang JY, Wilcox CM, Navaneethan U. et al. Treatment of walled-off necrosis using lumen-apposing metal stents versus plastic stents: a systematic review and meta-analysis of data from randomized trials. Endoscopy 2024; 56: 184-195
• 19 van Brunschot S, van Grinsven J, van Santvoort HC. et al. Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial. Lancet 2018; 391: 51-58
• 20 Chavan R, Nabi Z, Lakhtakia S. et al. Impact of transmural plastic stent on recurrence of pancreatic fluid collection after metal stent removal in disconnected pancreatic duct: a randomized controlled trial. Endoscopy 2022; 54: 861-868
• 21 Siddiqui A, Naveed M, Basha J. et al. International, multicenter retrospective trial comparing the efficacy and safety of bi-flanged versus lumen-apposing metal stents for endoscopic drainage of walled-off pancreatic necrosis. Ann Gastroenterol 2021; 34: 273-281
• 22 Boxhoorn L, Verdonk RC, Besselink MG. et al. Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis. Gut 2023; 72: 66-72