2,086
Views
9
CrossRef citations to date
0
Altmetric
Original Article

Uncovered versus covered metallic stents for the management of unresectable malignant distal biliary obstruction: a randomized multicenter trial

, , , , , , , , , & show all
Pages 1229-1235 | Received 26 Feb 2021, Accepted 30 May 2021, Published online: 10 Aug 2021

References

  • Miyazaki M, Yoshitomi H, Miyakawa S, et al. Clinical practice guidelines for the management of biliary tract cancers 2015: the 2nd English edition. J Hepatobiliary Pancreat Sci. 2015;22(4):249–273.
  • Davids PH, Groen AK, Rauws EA, et al. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992; 340:1488–1492.
  • Knyrim K, Wagner HJ, Pausch J, et al. A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct. Endoscopy. 1993;25(03):207–212.
  • Kaassis M, Boyer J, Dumas 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(2):178–182.
  • Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc. 2006;63:986–995.
  • Isayama H, Yasuda I, Ryozawa S, et al. Results of a Japanese multicenter, randomized trial of endoscopic stenting for non-resectable pancreatic head cancer (JM-test): covered Wallstent versus Double Layer stent. Dig Endosc. 2011;23:310–315.
  • Isayama H, Komatsu Y, Tsujino T, et al. Polyurethane-covered metal stent for management of distal malignant biliary obstruction. Gastrointest Endosc. 2002;55:366–370.
  • Isayama H, Komatsu Y, Tsujino T, et al. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of biliary distal malignant biliary obstruction. GUT. 2004;53:729–734.
  • Kullman E, Frozanpor F, Söderlund C, et al. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from randomized, multicenter study. Gastrointest Endosc. 2010;72:915–923.
  • Telford JJ, Carr-Locke DL, Baron TH, et al. A rondomized trial comparing uncovered and partially covered self-expandable metal stents in the palliatiion of distal malignant biliary obstruction. Gastrointest Endosc. 2010;72:907–914.
  • Kitano M, Yamashita Y, Tanaka K, 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(11):1713–1722.
  • Ung KA, Stotzer PO, Nilsson A, et al. 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;48:459–465.
  • Yang MJ, Kim JH, Yoo BM, et al. Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstructions: a randomized controlled trial. Scand J Gastroenterol. 2015;50:1490–1499.
  • Conio M, Mangiavillano B, Caruso A, et al. Covered versus uncovered self-expandable metal stents for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc. 2018;88:283–291.
  • Kiriyama S, Takada T, Strasberg S, et al. TG 13 guidelines for diagnosis and severity grading of acute choangitis (with videos). J Hepatobiliary Pancreat Sci. 2013;1:24–34.
  • Lakatos E. Sample sizes based on the log-rank statistic in complex clinical trials. Biometrics. 1988;44:229–241.
  • Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991;37(3):383–393.
  • Burris HA, 3rd, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with gemcitabine as a first- line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997;15:2403–2413.
  • Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A phase III trial of National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007;25(15):1960–1966.
  • Conroy T, Desseigne F, Ychou M, et al. FOLFILINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817–1825.
  • Okusaka T, Furuse J, Funakoshi A, et al. Phase II study of erlotinib plus gemcitabine in patients with unresectable pancreatic cancer. Cancer Sci. 2011;102:425–431.
  • Von Hoff DD, Ramanathan RK, Borad MJ, et al. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: 1 phaseI/II trial. J Clin Oncol. 2011;29:4548–4554.
  • Sasaki T, Isayama H, Nakai Y, et al. Improvement of prognosis for unresectable biliary tract cancer. WJG. 2013;19(1):72–77.
  • Isayama H, Mukai T, Itoi T, 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.
  • Sakai Y, Tsuyuguchi T, Hirata N, et al. Long term outcome of the WallFlex partially covered stent for unresectable malignant biliary obstruction: a multicenter single-arm prospective study. Hepatogastroenterology. 2013;60:1854–1860.
  • Isayama H, Nakai Y, Toyokawa Y, et al. Measurement of radial and axial force of biliary self-expandable metallic stents. Gastrointest Endosc. 2009;70(1):37–44.
  • Luigiano C, Ferrara F, Cennamo V, et al. A comparison of uncovered metal stents for the palliation of patients with malignant biliary obstruction: nitinol vs. stainless steel. Dig Liver Dis. 2012;44(2):128–133.
  • Saleem A, Leggett CL, Murad MH, et al. Meta-analysis of randomized trials comparing the patency of covered and uncovered self-expandable metal stents for palliation od distal malignant bile duct obstruction. Gastrointest Endosc. 2011;74:321–327.
  • 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.
  • Tringali A, Hassan C, Rota M, et al. Covered vs. uncovered self-expandable metal stents for malignant distal biliary strictures: a systematic review and meta-analysis. Endoscopy. 2018;50:631–641.