Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial

References

• Farley DR, Weaver AL, Nagorney DM. “Natural history” of unresected cholangiocarcinoma: patient outcome after noncurative intervention. Mayo Clin Proc 1995;70:425–9.
   PubMed Web of Science ®Google Scholar
• Kim JH. Endoscopic stent placement in the palliation of malignant biliary obstruction. Clin Endosc 2011;44:76–86.
   PubMedGoogle Scholar
• Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet 1992;340:1488–92.
   PubMed Web of Science ®Google Scholar
• Kaassis M, Boyer J, Dumas R, Ponchon T, Coumaros D, Delcenserie R, et al. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. Gastrointest Endosc 2003;57:178–82.
   PubMed Web of Science ®Google Scholar
• Knyrim K, Wagner HJ, Pausch J, Vakil N. A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct. Endoscopy 1993;25:207–12.
   PubMed Web of Science ®Google Scholar
• Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc 2006;63:986–95.
   PubMed Web of Science ®Google Scholar
• Almadi MA, Barkun AN, Martel M. No benefit of covered vs uncovered self-expandable metal stents in patients with malignant distal biliary obstruction: a meta-analysis. Clin Gastroenterol Hepatol 2013;11:27–37 e21.
   PubMed Web of Science ®Google Scholar
• Isayama H, Komatsu Y, Tsujino T, Sasahira N, Hirano K, Toda N, et al. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 2004;53:729–34.
   PubMed Web of Science ®Google Scholar
• Kitano M, Yamashita Y, Tanaka K, Konishi H, Yazumi S, Nakai Y, et al. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol 2013;108:1713–22.
   PubMed Web of Science ®Google Scholar
• Krokidis M, Fanelli F, Orgera G, Bezzi M, Passariello R, Hatzidakis A. Percutaneous treatment of malignant jaundice due to extrahepatic cholangiocarcinoma: covered Viabil stent versus uncovered Wallstents. Cardiovasc Intervent Radiol 2010;33:97–106.
   PubMed Web of Science ®Google Scholar
• Krokidis M, Fanelli F, Orgera G, Tsetis D, Mouzas I, Bezzi M, et al. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. Cardiovasc Intervent Radiol 2011;34:352–61.
   PubMed Web of Science ®Google Scholar
• Kullman E, Frozanpor F, Soderlund C, Linder S, Sandstrom P, Lindhoff-Larsson A, et al. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc 2010;72:915–23.
   PubMed Web of Science ®Google Scholar
• Park do H, Kim MH, Choi JS, Lee SS, Seo DW, Kim JH, et al. Covered versus uncovered wallstent for malignant extrahepatic biliary obstruction: a cohort comparative analysis. Clin Gastroenterol Hepatol 2006;4:790–6.
   PubMed Web of Science ®Google Scholar
• Saleem A, Leggett CL, Murad MH, Baron TH. Meta-analysis of randomized trials comparing the patency of covered and uncovered self-expandable metal stents for palliation of distal malignant bile duct obstruction. Gastrointest Endosc 2011;74:321–7.
   PubMed Web of Science ®Google Scholar
• Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, et al. A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc 2010;72:907–14.
   PubMed Web of Science ®Google Scholar
• Ung KA, Stotzer PO, Nilsson A, Gustavsson ML, Johnsson E. Covered and uncovered self-expandable metallic Hanarostents are equally efficacious in the drainage of extrahepatic malignant strictures. Results of a double-blind randomized study. Scand J Gastroenterol 2013;48:459–65.
   PubMed Web of Science ®Google Scholar
• Yoon WJ, Lee JK, Lee KH, Lee WJ, Ryu JK, Kim YT, et al. A comparison of covered and uncovered Wallstents for the management of distal malignant biliary obstruction. Gastrointest Endosc 2006;63:996–1000.
   PubMed Web of Science ®Google Scholar
• Lee JH, Krishna SG, Singh A, Ladha HS, Slack RS, Ramireddy S, et al. Comparison of the utility of covered metal stents versus uncovered metal stents in the management of malignant biliary strictures in 749 patients. Gastrointest Endosc 2013;78:312–24.
   PubMed Web of Science ®Google Scholar
• Lee SJ, Kim MD, Lee MS, Kim IJ, Park SI, Won JY, et al. Comparison of the efficacy of covered versus uncovered metallic stents in treating inoperable malignant common bile duct obstruction: a randomized trial. J Vasc Interv Radiol 2014;25:1912–20.
   PubMed Web of Science ®Google Scholar
• Ho H, Mahajan A, Gosain S, Jain A, Brock A, Rehan ME, et al. Management of complications associated with partially covered biliary metal stents. Dig Dis Sci 2010;55:516–22.
   PubMed Web of Science ®Google Scholar
• Nakai Y, Isayama H, Komatsu Y, Tsujino T, Toda N, Sasahira N, et al. Efficacy and safety of the covered Wallstent in patients with distal malignant biliary obstruction. Gastrointest Endosc 2005;62:742–8.
   PubMed Web of Science ®Google Scholar
• Suk KT, Kim HS, Kim JW, Baik SK, Kwon SO, Kim HG, et al. Risk factors for cholecystitis after metal stent placement in malignant biliary obstruction. Gastrointest Endosc 2006;64:522–9.
   PubMed Web of Science ®Google Scholar
• Willingham FF. All wrapped up: metal biliary stents and the effect of stent coverings. Gastrointest Endosc 2010;72:924–6.
   PubMed Web of Science ®Google Scholar
• Isayama H, Mukai T, Itoi T, Maetani I, Nakai Y, Kawakami H, et al. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study. Gastrointest Endosc 2012;76:84–92.
   PubMed Web of Science ®Google Scholar
• Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383–93.
   PubMed Web of Science ®Google Scholar
• Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, et al. TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci 2013;20:24–34.
   PubMed Web of Science ®Google Scholar
• Isayama H, Nakai Y, Toyokawa Y, Togawa O, Gon C, Ito Y, et al. Measurement of radial and axial forces of biliary self-expandable metallic stents. Gastrointest Endosc 2009;70:37–44.
   PubMed Web of Science ®Google Scholar
• Nakai Y, Isayama H, Kawakubo K, Kogure H, Hamada T, Togawa O, et al. Metallic stent with high axial force as a risk factor for cholecystitis in distal malignant biliary obstruction. J Gastroenterol Hepatol 2014;29:1557–62.
   PubMed Web of Science ®Google Scholar
• Nakai Y, Isayama H, Kogure H, Hamada T, Togawa O, Ito Y, et al. Risk factors for covered metallic stent migration in patients with distal malignant biliary obstruction due to pancreatic cancer. J Gastroenterol Hepatol 2014;29:1744–9.
   PubMed Web of Science ®Google Scholar
• Sakai Y, Tsuyuguchi T, Hirata N, Sugiyama H, Shimura K, Nakaji S, et al. Long-term outcome of the WallFlex partially covered stent for unresectable malignant biliary obstruction: a multicenter single-arm prospective study. Hepatogastroenterology 2013;60:1854–60.
   PubMed Web of Science ®Google Scholar
• Park SB, Kim HW, Kang DH, Choi CW, Ryu JH, Chu CW, et al. Metallic or plastic stent for bile duct obstruction in ampullary cancer? Dig Dis Sci 2012;57:786–90.
   PubMed Web of Science ®Google Scholar
• Leung JW, Liu YL, Desta T, Libby E, Inciardi JF, Lam K. Is there a synergistic effect between mixed bacterial infection in biofilm formation on biliary stents? Gastrointest Endosc 1998;48:250–7.
   PubMed Web of Science ®Google Scholar