Subscribe to RSS
Evaluation of a 12-mm diameter covered self-expandable end bare metal stent for malignant biliary obstruction
submitted 04 December 2017
accepted after revision 27 April 2018
08 October 2018 (online)
Background and study aims Biliary metallic stents are used to drain unresectable malignant distal biliary obstructions. This study aimed to evaluate the efficacy of a novel 12-mm-diameter covered, self-expandable end bare metal stent (12-mm CSEEMS).
Patients and methods We evaluated 99 patients with unresectable malignant distal biliary obstructions treated with covered biliary metallic stents. Of the 99 patients, 33 underwent 12-mm CSEEMS placement between June 2015 and April 2017 (12-mm-CSEEMS group) and 66 underwent 10-mm fully-covered self-expandable metal stent (FCSEMS) placement between January 2010 and July 2015 (10-mm-FCSEMS group). The overall survival (OS), the recurrent biliary obstruction (RBO), cause of RBO, time to RBO (TRBO) and adverse events in 12-mm-CSEEMS group and 10-mm-FCSEMS group were evaluated retrospectively.
Results The OS tended to be longer in the 12-mm-CSEEMS group (log rank, P = 0.081) and TRBO was significantly longer in the 12-mm-CSEEMS group (log rank, P = 0.001) than in the 10-mm-FCSEMS group. Both univariate (HR, 0.449; 95 % CI, 0.27967 – 0.72215; P = 0.001) and multivariate (HR, 0.458; 95 % CI, 0.28395 – 0.73744; P = 0.001) Cox hazard analysis found that risk of RBO was significantly lower in 12-mm CSEEMS than in 10-mm FCSEMS. There were no significant differences between the 12-mm-CSEEMS group and 10-mm-FCSEMS group regarding the cause of RBO and adverse events.
Conclusions The 12-mm CSEEMS showed a low risk of RBO compared with 10-mm FCSEMS and was considered to be effective and safe for draining unresectable malignant distal biliary obstruction.
- 1 Irving JD, Adam A, Dick R. et al. Gianturco expandable metallic biliary stents: results of a European clinical trial. Radiology 1989; 172: 321-326
- 2 Lammer J, Klein GE, Kleinert R. et al. Obstructive jaundice: use of expandable metal endoprosthesis for biliary drainage. Work in progress. Radiology 1990; 177: 789-792
- 3 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
- 4 Hoepffner N, Foerster EC, Hogemann B. et al. Long-term experience in Wallstent therapy for malignant choledochal stenosis. Endoscopy 1994; 26: 597-602
- 5 Isayama H, Komatsu Y, Tsujino T. et al. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 2004; 53: 729-734
- 6 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 of distal malignant bile duct obstruction. Gastrointest Endosc 2011; 74: 321-327.e321-323
- 7 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: 1713-1722
- 8 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
- 9 Mukai T, Yasuda I, Isayama H. et al. Pilot study of a novel, large-bore, fully covered self-expandable metallic stent for unresectable distal biliary malignancies. Dig Endosc 2016; 28: 671-679
- 10 Isayama H, Nakai Y, Toyokawa Y. et al. Measurement of radial and axial forces of biliary self-expandable metallic stents. Gastrointest Endosc 2009; 70: 37-44
- 11 Isayama H, Hamada T, Yasuda I. et al. TOKYO criteria 2014 for transpapillary biliary stenting. Dig Endosc 2015; 27: 259-264
- 12 Ramanathan RK, Goldstein D, Korn RL. et al. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol 2016; 27: 648-653
- 13 Conroy T, Desseigne F, Ychou M. et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011; 364: 1817-1825
- 14 Chen MY, Lin JW, Zhu HP. et al. Covered Stents versus uncovered stents for unresectable malignant biliary strictures: a meta-analysis. BioMed Res Int 2016; 2016: 6408067
- 15 Yang Z, Wu Q, Wang F. et al. A systematic review and meta-analysis of randomized trials and prospective studies comparing covered and bare self-expandable metal stents for the treatment of malignant obstruction in the digestive tract. Int J Med Sci 2013; 10: 825-835
- 16 Li J, Li T, Sun P. et al. Covered versus uncovered self-expandable metal stents for managing malignant distal biliary obstruction: a meta-analysis. PloS One 2016; 11: e0149066
- 17 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
- 18 Kawakubo K, Isayama H, Nakai Y. et al. Risk factors for pancreatitis following transpapillary self-expandable metal stent placement. Surg Endosc 2012; 26: 771-776
- 19 Isayama H, Kawabe T, Nakai Y. et al. Cholecystitis after metallic stent placement in patients with malignant distal biliary obstruction. Clin Gastroenterol Hepatol 2006; 4: 1148-1153
- 20 Suk KT, Kim HS, Kim JW. et al. Risk factors for cholecystitis after metal stent placement in malignant biliary obstruction. Gastrointest Endosc 2006; 64: 522-529