Safety and efficacy of lumen-apposing metal stents versus plastic stents to treat walled-off pancreatic necrosis: systematic review and meta-analysis

Abstract

Background and study aims Lumen-apposing metal stents (LAMS) are increasingly used for drainage of walled-off pancreatic necrosis (WON). Recent studies suggested greater adverse event (AE) rates with LAMS for WON. We conducted a systematic review and meta-analysis to compare the safety and efficacy of LAMS with double-pigtail plastic stents (DPPS) for endoscopic drainage of WON. The primary aim was to evaluate stent-related AEs.

Methods In October 2019, we searched the Ovid (Embase, MEDLINE, Cochrane) and Scopus databases for studies assessing a specific LAMS or DPPS for WON drainage conducted under EUS guidance. Safety outcomes were AE rates of bleeding, stent migration, perforation, and stent occlusion. Efficacy outcomes were WON resolution and number of procedures needed to achieve resolution. A subanalysis including non-EUS-guided cases was performed.

Results Thirty studies including one randomized controlled trial (total 1,524 patients) were analyzed. LAMS were associated with similar bleeding (2.5 % vs. 4.6 %, P = 0.39) and perforation risk (0.5 % vs. 1.1 %, P = 0.35) compared to DPPS. WON resolution (87.4 % vs. 87.5 %, P = 0.99), number of procedures to achieve resolution (2.09 vs. 1.88, P = 0.72), stent migration (5.9 % vs. 6.8 %, P = 0.79), and stent occlusion (3.8 % vs. 5.2 %, P = 0.78) were similar for both groups. Inclusion of non-EUS-guided cases led to significantly higher DPPS bleeding and perforation rates.

Conclusions LAMS and DPPS were associated with similar rates of AEs and WON resolution when limiting analysis to EUS-guided cases. Higher bleeding rates were seen in historical studies of DPPS without EUS guidance. Additional high-quality studies of WON treatment using consistent outcome definitions are needed.

• References

• 1 Peery AF, Crockett SD, Murphy CC. et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: update 2018. Gastroenterology 2019; 156: 254-272.e11
• 2 Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology 2013; 144: 1252-1261
• 3 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
• 4 Aparna D, Kumar S, Kamalkumar S. Mortality and morbidity in necrotizing pancreatitis managed on principles of step-up approach: 7 years experience from a single surgical unit. World J Gastrointest Surg 2017; 9: 200-208
• 5 Ashley SW, Perez A, Pierce EA. et al. Necrotizing pancreatitis: contemporary analysis of 99 consecutive cases. Ann Surg 2001; 234: 572-579 ; discussion 579-580
• 6 Schmid SW, Uhl W, Friess H. et al. The role of infection in acute pancreatitis. Gut 1999; 45: 311-316
• 7 Petrov MS, Shanbhag S, Chakraborty M. et al. Organ failure and infection of pancreatic necrosis as determinants of mortality in patients with acute pancreatitis. Gastroenterology 2010; 139: 813-820
• 8 Muthusamy VR, Chandrasekhara V, Acosta RD. et al. The role of endoscopy in the diagnosis and treatment of inflammatory pancreatic fluid collections. Gastrointestinal endoscopy 2016; 83: 481-488
• 9 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: 2054-2056
• 10 Tarantino I, Ligresti D, Tuzzolino F. et al. Clinical impact of EUS treatment of walled–off pancreatic necrosis with dedicated devices. Endosc Int Open 2017; 5: E784-E791
• 11 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;
• 12 Sahar N, Kozarek R, Kanji ZS. et al. Do lumen-apposing metal stents (LAMS) improve treatment outcomes of walled-off pancreatic necrosis over plastic stents using dual-modality drainage?. Endosc Int Open 2017; 5: E1052-E1059
• 13 Zhu H, Lin H, Jin Z. et al. Re-evaluation of the role of lumen-apposing metal stents (LAMS) for pancreatic fluid collection drainage. Gut 2017; 66: 2192
• 14 Garcia-Alonso FJ, Sanchez-Ocana R, Penas-Herrero I. et al. Cumulative risks of stent migration and gastrointestinal bleeding in patients with lumen–apposing metal stents. Endoscopy 2018; 50: 386-395
• 15 Zeissig S, Sulk S, Brueckner S. et al. Severe bleeding is a rare event in patients receiving lumen-apposing metal stents for the drainage of pancreatic fluid collections. Gut 2019; 68: 945-946
• 16 Mussetto A, Fugazza A, Fuccio L. et al. Current uses and outcomes of lumen-apposing metal stents. Annals of gastroenterology 2018; 31: 535
• 17 DeSimone ML, Asombang AW, Berzin TM. Lumen apposing metal stents for pancreatic fluid collections: Recognition and management of complications. World J Gastrointest Endosc 2017; 9: 456-463
• 18 Bazerbachi F, Sawas T, Vargas EJ. et al. Metal stents versus plastic stents for the management of pancreatic walled-off necrosis: a systematic review and meta-analysis. Gastrointest Endosc 2018; 87: 30-42.e15
• 19 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
• 20 Moher D, Liberati A, Tetzlaff J. et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009; 6: e1000097
• 21 Haffar S, Bazerbachi F, Prokop L. et al. Frequency and prognosis of acute pancreatitis associated with fulminant or non-fulminant acute hepatitis A: A systematic review. Pancreatology 2017; 17: 166-175
• 22 Bazerbachi F, Leise MD, Watt KD. et al. Systematic review of mixed cryoglobulinemia associated with hepatitis E virus infection: association or causation?. Gastroenterol Rep (Oxf) 2017; 5: 178-184
• 23 Murad MH, Sultan S, Haffar S. et al. Methodological quality and synthesis of case series and case reports. BMJ Evid Based Med 2018; 23: 60-63
• 24 Higgins JP, Thompson SG, Deeks JJ. et al. Measuring inconsistency in meta-analyses. BMJ 2003; 327: 557-560
• 25 Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994; 1088-1101
• 26 Egger M, Smith GD, Schneider M. et al. Bias in meta–analysis detected by a simple, graphical test. BMJ 1997; 315: 629-634
• 27 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: 389-393
• 28 Bekkali NLH, Nayar MK, Leeds JS. et al. A comparison of outcomes between a lumen-apposing metal stent with electrocautery-enhanced delivery system and a bi-flanged metal stent for drainage of walled-off pancreatic necrosis. Endosc Int Open 2017; 5: E1189-E1196
• 29 Law ST, De La Serna Higuera C, Simón PG. et al. Comparison of clinical efficacies and safeties of lumen-apposing metal stent and conventional-type metal stent-assisted EUS-guided pancreatic wall-off necrosis drainage: a real-life experience in a tertiary hospital. Surg Endosc 2018; 32: 2448-2453
• 30 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-E1275
• 31 Baron TH, DiMaio CJ, Wang AY. et al. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology 2020; 158: 67-75
• 32 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
• 33 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
• 34 He WH, Zhu Y, Liu P. et al. The outcomes of initial endoscopic transluminal drainage are superior to percutaneous drainage for patients with infected pancreatic necrosis: a prospective cohort study. Surg Endosc 2017; 31: 3004-3013
• 35 Tenner S, Baillie J, DeWitt J. et al. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol 2013; 108: 1400-1416
• 36 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
• 37 Consiglieri CF, Gornals JB, Busquets J. et al. Fluoroscopy-assisted vs fluoroless endoscopic ultrasound-guided transmural drainage of pancreatic fluid collections: A comparative study. Gastroenterol Hepatol 2018; 41: 12-21
• 38 Garg R, Chaar A, Szpunar S. et al. Efficacy and safety of lumen-apposing stents for management of pancreatic fluid collections in a community hospital setting. Clinical Endoscopy 2020; 53: 480-486
• 39 Storm AC, Thompson CC. Safety of direct endoscopic necrosectomy in patients with gastric varices. World J Gastrointest Endosc 2016; 8: 402-408
• 40 Rana SS, Kumar A, Lal A. et al. Safety and efficacy of angioembolisation followed by endoscopic ultrasound guided transmural drainage for pancreatic fluid collections associated with arterial pseudoaneurysm. Pancreatology 2017; 17: 658-662
• 41 Kumar N, Conwell DL, Thompson CC. Direct endoscopic necrosectomy versus step-up approach for walled-off pancreatic necrosis: comparison of clinical outcome and health care utilization. Pancreas 2014; 43: 1334-1339
• 42 Lin H, Zhan XB, Sun SY. et al. Stent selection for endoscopic ultrasound–guided drainage of pancreatic fluid collections: a multicenter study in china. Gastroenterol Res Pract 2014; 2014: 193562
• 43 Rana SS, Bhasin DK, Sharma RK. et al. Do the morphological features of walled off pancreatic necrosis on endoscopic ultrasound determine the outcome of endoscopic transmural drainage?. Endosc Ultrasound 2014; 3: 118-122
• 44 Rana SS, Bhasin DK, Sharma R. et al. Factors determining recurrence of fluid collections following migration of intended long term transmural stents in patients with walled off pancreatic necrosis and disconnected pancreatic duct syndrome. Endosc Ultrasound 2015; 4: 208-212
• 45 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
• 46 Smoczyński M, Jagielski M, Jabłońska A. et al. Endoscopic necrosectomy under fluoroscopic guidance – a single center experience. Wideochir Inne Tech Maloinwazyjne 2015; 10: 237-243
• 47 Walter D, Will U, Sanchez-Yague A. et al. A novel lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections: a prospective cohort study. Endoscopy 2015; 47: 63-67
• 48 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
• 49 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
• 50 Thompson CC, Kumar N, Slattery J. et al. A standardized method for endoscopic necrosectomy improves complication and mortality rates. Pancreatology 2016; 16: 66-72
• 51 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
• 52 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
• 53 Ren YC, Chen SM, Cai XB. et al. Endoscopic ultrasonography-guided drainage combined with trans-duodenoscope cyclic irrigation technique for walled-off pancreatic necrosis. Dig Liver Dis 2017; 49: 38-44
• 54 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
• 55 Watanabe Y, Mikata R, Yasui S. et al. Short- and long-term results of endoscopic ultrasound-guided transmural drainage for pancreatic pseudocysts and walled-off necrosis. World J Gastroenterol 2017; 23: 7110-7118
• 56 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
• 57 Shekhar C, Maher B, Forde C. et al. Endoscopic ultrasound-guided pancreatic fluid collectionsʼ transmural drainage outcomes in 100 consecutive cases of pseudocysts and walled off necrosis: a single-centre experience from the United Kingdom. Scand J Gastroenterol 2017;
• 58 Venkatachalapathy SV, Bekkali N, Pereira S. et al. Multicenter experience from the UK and Ireland of use of lumen-apposing metal stent for transluminal drainage of pancreatic fluid collections. Endosc Int Open 2018; 6: E259-E265
• 59 Chen Y-I, 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