A multicenter, prospective study of a new fully covered expandable metal biliary stent for the palliative treatment of malignant bile duct obstruction.

Authors

Bret T Petersen, Mayo Clinic, 200 1st Street SW, Rochester, MN
Michel Kahaleh, Weill Cornell Medical College
Richard A Kozarek, Virginia Mason Seattle Main Clinic, 1100 Ninth Avenue, Seattle, WA
David E. Loren, Jefferson Medical CollegeFollow
Kapil Gupta, Cedars-Sinai Medical Center, 8700 Beverly Bl No. 7511, Los Angeles, CA
Thomas E. Kowalski, Thomas Jefferson UniversityFollow
Martin Freeman, Hennepin County Medical Center, MMC 36, 420 Delaware Street SE, Minneapolis, MN
Yang K Chen, University of Colorado Boulder
Malcolm S Branch, Duke University
Steven Edmundowicz, Washington University, School of Medicine, 660 South Euclid Avenue, Campus Box 8124, St. Louis, MO
Michael Gluck, Virginia Mason Seattle Main Clinic, 1100 Ninth Avenue, Seattle, WA
Kenneth Binmoeller, California Pacific Medical Center, 2351 Clay Street No. 304, San Francisco, CA
Todd H Baron, Mayo Clinic, 200 1st Street SW, Rochester, MN
Raj J Shah, University of Colorado
Timothy Kinney, Hennepin County Medical Center, Medicine Office, GI 865B, 701 Park Avenue, Minneapolis, MN
William Ross, The University of Texas MD Anderson Cancer Center, 1400 Pressler, Unit Number: Unit 1466, Houston, TX
Paul Jowell, Duke University
David Carr-Locke, Brigham and Women's Hospital, Boston, MA

Document Type

Article

Publication Date

1-1-2013

Comments

This article has been peer reviewed. It was published in: Gastroenterology research and practice.

2013:642428.

The published version is available at DOI: 10.1155/2013/642428 Copyright © Hindawi

Abstract

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.

Recommended Citation

Petersen, Bret T; Kahaleh, Michel; Kozarek, Richard A; Loren, David E.; Gupta, Kapil; Kowalski, Thomas E.; Freeman, Martin; Chen, Yang K; Branch, Malcolm S; Edmundowicz, Steven; Gluck, Michael; Binmoeller, Kenneth; Baron, Todd H; Shah, Raj J; Kinney, Timothy; Ross, William; Jowell, Paul; and Carr-Locke, David, "A multicenter, prospective study of a new fully covered expandable metal biliary stent for the palliative treatment of malignant bile duct obstruction." (2013). Division of Gastroenterology and Hepatology Faculty Papers. Paper 22.
https://jdc.jefferson.edu/gastro_hepfp/22

PubMed ID

23606835