Hindawi Publishing Corporation Gastroenterology Research and Practice Volume 2013, Article ID 642428, 7 pages http://dx.doi.org/10.1155/2013/642428 Research Article A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction Bret T. Petersen, 1 Michel Kahaleh, 2,3 Richard A. Kozarek, 4 David Loren, 5 Kapil Gupta, 6,7 Thomas Kowalski, 5 Martin Freeman, 8 Yang K. Chen, 9 Malcolm S. Branch, 10 Steven Edmundowicz, 11 Michael Gluck, 4 Kenneth Binmoeller, 12 Todd H. Baron, 1 Raj J. Shah, 13 Timothy Kinney, 14 William Ross, 15 Paul Jowell, 10 and David Carr-Locke 16,17 1 Charlton 8, GI Endoscopy, Mayo Clinic, 200 1st Street SW, Rochester, MN 55905, USA 2 Weill Cornell Medical College, 1305 York Avenue, 4th Floor, New York, NY 10065, USA 3 University of Virginia, Charlottesville, VA, USA 4 Virginia Mason Seattle Main Clinic, 1100 Ninth Avenue, Seattle, WA 98101, USA 5 Tomas Jeferson University, Main Building, Suite 480, 132 South 10th Street, Philadelphia, PA 19107, USA 6 Cedars-Sinai Medical Center, 8700 Beverly Bl No. 7511, Los Angeles, CA 90048, USA 7 Hennepin County Medical Center, Minneapolis, MN, USA 8 GI Division, Department of Medicine, Hennepin County Medical Center, MMC 36, 420 Delaware Street SE, Minneapolis, MN 55455, USA 9 University of Colorado Boulder, Campus Box F735, Anschutz Inpatient Pavilion (AIP), S/M Gastroenterology, Terapeutic Endoscopy, USA 10 Duke University, DUMC 3662, Durham, NC 27710, USA 11 Washington University, School of Medicine, 660 South Euclid Avenue, Campus Box 8124, St. Louis, MO 63110, USA 12 California Pacifc Medical Center, 2351 Clay Street No. 304, San Francisco, CA 94115, USA 13 University of Colorado, Campus Box F735, Anschutz Outpatient Pavilion (AOP), Room 2136-A, P.O. Box 6510, Aurora, CO 80045, USA 14 Hennepin County Medical Center, Medicine Ofce, GI 865B, 701 Park Avenue, Minneapolis, MN 55415, USA 15 Te University of Texas MD Anderson Cancer Center, 1400 Pressler, Unit Number: Unit 1466, Houston, TX 77030, USA 16 Beth Israel Medical Center, 10 Union Square East, Suite 2G, New York, NY 10003, USA 17 Brigham and Women’s Hospital, Boston, MA 02215, USA Correspondence should be addressed to Bret T. Petersen; petersen.bret@mayo.edu Received 19 September 2012; Accepted 22 January 2013 Academic Editor: Gianfranco D. Alpini Copyright © 2013 Bret T. Petersen et al. Tis is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background and Study Aims. Endoscopic placement of self-expanding metal stents (SEMSs) is indicated for palliation of inoperable malignant biliary obstruction. A fully covered biliary SEMS (WallFlex Biliary RX Boston Scientifc, Natick, USA) was assessed for palliation of extrahepatic malignant biliary obstruction. Patients and Methods. 58 patients were included in this prospective, multicenter series conducted under an FDA-approved IDE. Main outcome measurements included (1) absence of stent occlusion within six months or until death, whichever occurred frst and (2) technical success, need for reintervention, bilirubin levels, stent patency, time to stent occlusion, and adverse events. Results. Technical success was achieved in 98% (57/58), with demonstrated acute removability in two patients. Adequate clinical palliation until completion of followup was achieved in 98% (54/55) of evaluable patients, with 1 reintervention due to stent obstruction afer 142 days. Mean total bilirubin decreased from 8.9 mg/dL to 1.2 mg/dL at 1 month. Device-related adverse events were limited and included 2 cases of cholecystitis. One stent migrated following radiation therapy. Conclusions. Te WallFlex Biliary fully covered stent yielded technically successful placement with uncomplicated acute removal where required, appropriate reduction in bilirubin levels, and low rates of stent migration and occlusion. Tis SEMS allows successful palliation of malignant extrahepatic biliary obstruction.