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

Vinay Chandrasekhara, Marc Barthet, Jacques Devière, Fateh Bazerbachi, Sundeep Lakhtakia, Jeffrey J Easler, Joyce A Peetermans, Edmund McMullen, Ornela Gjata, Margaret L Gourlay, Barham K Abu Dayyeh, Vinay Chandrasekhara, Marc Barthet, Jacques Devière, Fateh Bazerbachi, Sundeep Lakhtakia, Jeffrey J Easler, Joyce A Peetermans, Edmund McMullen, Ornela Gjata, Margaret L Gourlay, Barham K Abu Dayyeh

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.

Conflict of interest statement

Competing interests Dr. Chandrasekhara is on the Advisory Board of Interpace Diagnostics and is a shareholder in Nevakar Corporation. Dr. Barthet received a research grant from Boston Scientific Corporation. Dr. Devière has received grants from Boston Scientific Corporation, Cook Endoscopy, and Olympus, and is a shareholder in Endotools. Dr. Easler is a consultant for Boston Scientific Corporation. Dr. Peetermans, Mr. McMullen, Ms. Gjata, and Dr. Gourlay are full – time employees of Boston Scientific Corporation. Dr. Abu Dayyeh received a research grant and consultation fee from Boston Scientific Corporation, research support from Medtronic, and education/lecture fees from Olympus.

The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Figures

Fig. 1
Fig. 1
Flow diagram of literature search and study selection.
Fig. 2
Fig. 2
Analysis of safety outcomes. Outcomes forableeding.
Fig. 2
Fig. 2
Analysis of safety outcomes. Outcomes forbperforation.
Fig. 2
Fig. 2
Analysis of safety outcomes. Outcomes forcstent migration.
Fig. 2
Fig. 2
Analysis of safety outcomes. Outcomes fordstent occlusion.
Fig. 3
Fig. 3
Analysis of efficacy outcomes. Outcomes foraresolution of WON.
Fig. 3
Fig. 3
Analysis of efficacy outcomes. Outcomes forbtotal number of endoscopic procedures to achieve resolution.

References

    1. Peery A F, Crockett S D, Murphy C C et al.Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: update 2018. Gastroenterology. 2019;156:254–2.72E13.
    1. Yadav D, Lowenfels A B. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013;144:1252–1261.
    1. Banks P A, Bollen T L, Dervenis C et al.Classification of acute pancreatitis – 2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013;62:102–111.
    1. 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.
    1. Ashley S W, Perez A, Pierce E A.Necrotizing pancreatitis: contemporary analysis of 99 consecutive cases Ann Surg 2001234572–579.; discussion 579-580
    1. Schmid S W, Uhl W, Friess H et al.The role of infection in acute pancreatitis. Gut. 1999;45:311–316.
    1. Petrov M S, 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.
    1. Muthusamy V R, Chandrasekhara V, Acosta R D et al.The role of endoscopy in the diagnosis and treatment of inflammatory pancreatic fluid collections. Gastrointestinal endoscopy. 2016;83:481–488.
    1. Bang J Y, 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.
    1. 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.
    1. Brimhall B, Han S, Tatman P D 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 doi: 10.1016/j.cgh.2018.02.021.
    1. Sahar N, Kozarek R, Kanji Z S et 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.
    1. Zhu H, Lin H, Jin Z et -evaluation of the role of lumen-apposing metal stents (LAMS) for pancreatic fluid collection drainage. Gut. 2017;66:2192.
    1. Garcia-Alonso F J, 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.
    1. 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.
    1. Mussetto A, Fugazza A, Fuccio L et al.Current uses and outcomes of lumen-apposing metal stents. Annals of gastroenterology. 2018;31:535.
    1. DeSimone M L, Asombang A W, Berzin T M. Lumen apposing metal stents for pancreatic fluid collections: Recognition and management of complications. World J Gastrointest Endosc. 2017;9:456–463.
    1. Bazerbachi F, Sawas T, Vargas E J et al.Metal stents versus plastic stents for the management of pancreatic walled-off necrosis: a systematic review and meta-analysis. Gastrointest Endosc. 2018;87:30–4.2E16.
    1. Abu Dayyeh B K, 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.
    1. 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.
    1. 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.
    1. Bazerbachi F, Leise M D, Watt K D et al.Systematic review of mixed cryoglobulinemia associated with hepatitis E virus infection: association or causation? Gastroenterol Rep (Oxf) 2017;5:178–184.
    1. Murad M H, Sultan S, Haffar S et al.Methodological quality and synthesis of case series and case reports. BMJ Evid Based Med. 2018;23:60–63.
    1. Higgins J P, Thompson S G, Deeks J J et al.Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–560.
    1. Begg C B, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics. 1994:1088–1101.
    1. Egger M, Smith G D, Schneider M et al.Bias in meta–analysis detected by a simple, graphical test. BMJ. 1997;315:629–634.
    1. Adler D G, Taylor L J, 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.
    1. Bekkali N LH, Nayar M K, Leeds J S 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.
    1. Law S T, De La Serna Higuera C, Simón P G 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.
    1. Yang D, Perbtani Y B, Mramba L K 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.
    1. Baron T H, DiMaio C J, Wang A Y et al.American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020;158:67–75.
    1. Bang J Y, Navaneethan U, Hasan M K 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.
    1. 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.
    1. He W H, 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.
    1. Tenner S, Baillie J, DeWitt J et al.American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013;108:1400–1416.
    1. Lang G D, 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.
    1. Consiglieri C F, Gornals J B, 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.
    1. Garg R, Chaar A, Szpunar S. Efficacy and safety of lumen-apposing stents for management of pancreatic fluid collections in a community hospital setting. Clinical Endoscopy. 2020;53:480–486.
    1. Storm A C, Thompson C C. Safety of direct endoscopic necrosectomy in patients with gastric varices. World J Gastrointest Endosc. 2016;8:402–408.
    1. Rana S S, 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.
    1. Kumar N, Conwell D L, Thompson C C. 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.
    1. Lin H, Zhan X B, Sun S Y et al.Stent selection for endoscopic ultrasound–guided drainage of pancreatic fluid collections: a multicenter study in china. Gastroenterol Res Pract. 2014;2014:193562.
    1. Rana S S, Bhasin D K, Sharma R K et the morphological features of walled off pancreatic necrosis on endoscopic ultrasound determine the outcome of endoscopic transmural drainage? Endosc Ultrasound. 2014;3:118–122.
    1. Rana S S, Bhasin D K, 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.
    1. 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.
    1. 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.
    1. 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.
    1. Sharaiha R Z, Tyberg A, Khashab M A 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.
    1. Siddiqui A A, Adler D G, 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.
    1. Thompson C C, Kumar N, Slattery J et al.A standardized method for endoscopic necrosectomy improves complication and mortality rates. Pancreatology. 2016;16:66–72.
    1. Bang J Y, Hasan M K, Navaneethan U et al.Lumen-apposing metal stents for drainage of pancreatic fluid collections: When and for whom? Dig Endosc. 2017;29:83–90.
    1. Bapaye A, Dubale N A, Sheth K A 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.
    1. Ren Y C, Chen S M, Cai X B 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.
    1. Siddiqui A A, Kowalski T E, Loren D E 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.
    1. 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.
    1. 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.
    1. 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 doi: 10.1080/00365521.2017.1398346.
    1. Venkatachalapathy S V, 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.
    1. 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.

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