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Gastroenterology Research and Practice
Volume 2013 (2013), Article ID 642428, 7 pages
Research Article

A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

1Charlton 8, GI Endoscopy, Mayo Clinic, 200 1st Street SW, Rochester, MN 55905, USA
2Weill Cornell Medical College, 1305 York Avenue, 4th Floor, New York, NY 10065, USA
3University of Virginia, Charlottesville, VA, USA
4Virginia Mason Seattle Main Clinic, 1100 Ninth Avenue, Seattle, WA 98101, USA
5Thomas Jefferson University, Main Building, Suite 480, 132 South 10th Street, Philadelphia, PA 19107, USA
6Cedars-Sinai Medical Center, 8700 Beverly Bl No. 7511, Los Angeles, CA 90048, USA
7Hennepin County Medical Center, Minneapolis, MN, USA
8GI Division, Department of Medicine, Hennepin County Medical Center, MMC 36, 420 Delaware Street SE, Minneapolis, MN 55455, USA
9University of Colorado Boulder, Campus Box F735, Anschutz Inpatient Pavilion (AIP), S/M Gastroenterology, Therapeutic Endoscopy, USA
10Duke University, DUMC 3662, Durham, NC 27710, USA
11Washington University, School of Medicine, 660 South Euclid Avenue, Campus Box 8124, St. Louis, MO 63110, USA
12California Pacific Medical Center, 2351 Clay Street No. 304, San Francisco, CA 94115, USA
13University of Colorado, Campus Box F735, Anschutz Outpatient Pavilion (AOP), Room 2136-A, P.O. Box 6510, Aurora, CO 80045, USA
14Hennepin County Medical Center, Medicine Office, GI 865B, 701 Park Avenue, Minneapolis, MN 55415, USA
15The University of Texas MD Anderson Cancer Center, 1400 Pressler, Unit Number: Unit 1466, Houston, TX 77030, USA
16Beth Israel Medical Center, 10 Union Square East, Suite 2G, New York, NY 10003, USA
17Brigham and Women’s Hospital, Boston, MA 02215, USA

Received 19 September 2012; Accepted 22 January 2013

Academic Editor: Gianfranco D. Alpini

Copyright © 2013 Bret T. Petersen et al. This 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 Scientific, 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 first 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 achievedin 98% (54/55) of evaluable patients, with 1 reintervention due to stent obstruction after 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. The 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. This SEMS allows successful palliation of malignant extrahepatic biliary obstruction.