A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
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 bili...
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Wiley
2013-01-01
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| Series: | Gastroenterology Research and Practice |
| Online Access: | http://dx.doi.org/10.1155/2013/642428 |
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| author | Bret T. Petersen Michel Kahaleh Richard A. Kozarek David Loren Kapil Gupta Thomas Kowalski Martin Freeman Yang K. Chen Malcolm S. Branch Steven Edmundowicz Michael Gluck Kenneth Binmoeller Todd H. Baron Raj J. Shah Timothy Kinney William Ross Paul Jowell David Carr-Locke |
| author_facet | Bret T. Petersen Michel Kahaleh Richard A. Kozarek David Loren Kapil Gupta Thomas Kowalski Martin Freeman Yang K. Chen Malcolm S. Branch Steven Edmundowicz Michael Gluck Kenneth Binmoeller Todd H. Baron Raj J. Shah Timothy Kinney William Ross Paul Jowell David Carr-Locke |
| author_sort | Bret T. Petersen |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-16529c927eec412098f320e4dd4f2466 |
| institution | Kabale University |
| issn | 1687-6121 1687-630X |
| language | English |
| publishDate | 2013-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Gastroenterology Research and Practice |
| spelling | doaj-art-16529c927eec412098f320e4dd4f24662025-02-03T01:26:12ZengWileyGastroenterology Research and Practice1687-61211687-630X2013-01-01201310.1155/2013/642428642428A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct ObstructionBret T. Petersen0Michel Kahaleh1Richard A. Kozarek2David Loren3Kapil Gupta4Thomas Kowalski5Martin Freeman6Yang K. Chen7Malcolm S. Branch8Steven Edmundowicz9Michael Gluck10Kenneth Binmoeller11Todd H. Baron12Raj J. Shah13Timothy Kinney14William Ross15Paul Jowell16David Carr-Locke17Charlton 8, GI Endoscopy, Mayo Clinic, 200 1st Street SW, Rochester, MN 55905, USAWeill Cornell Medical College, 1305 York Avenue, 4th Floor, New York, NY 10065, USAVirginia Mason Seattle Main Clinic, 1100 Ninth Avenue, Seattle, WA 98101, USAThomas Jefferson University, Main Building, Suite 480, 132 South 10th Street, Philadelphia, PA 19107, USACedars-Sinai Medical Center, 8700 Beverly Bl No. 7511, Los Angeles, CA 90048, USAThomas Jefferson University, Main Building, Suite 480, 132 South 10th Street, Philadelphia, PA 19107, USAGI Division, Department of Medicine, Hennepin County Medical Center, MMC 36, 420 Delaware Street SE, Minneapolis, MN 55455, USAUniversity of Colorado Boulder, Campus Box F735, Anschutz Inpatient Pavilion (AIP), S/M Gastroenterology, Therapeutic Endoscopy, USADuke University, DUMC 3662, Durham, NC 27710, USAWashington University, School of Medicine, 660 South Euclid Avenue, Campus Box 8124, St. Louis, MO 63110, USAVirginia Mason Seattle Main Clinic, 1100 Ninth Avenue, Seattle, WA 98101, USACalifornia Pacific Medical Center, 2351 Clay Street No. 304, San Francisco, CA 94115, USACharlton 8, GI Endoscopy, Mayo Clinic, 200 1st Street SW, Rochester, MN 55905, USAUniversity of Colorado, Campus Box F735, Anschutz Outpatient Pavilion (AOP), Room 2136-A, P.O. Box 6510, Aurora, CO 80045, USAHennepin County Medical Center, Medicine Office, GI 865B, 701 Park Avenue, Minneapolis, MN 55415, USAThe University of Texas MD Anderson Cancer Center, 1400 Pressler, Unit Number: Unit 1466, Houston, TX 77030, USADuke University, DUMC 3662, Durham, NC 27710, USABeth Israel Medical Center, 10 Union Square East, Suite 2G, New York, NY 10003, USABackground 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.http://dx.doi.org/10.1155/2013/642428 |
| spellingShingle | Bret T. Petersen Michel Kahaleh Richard A. Kozarek David Loren Kapil Gupta Thomas Kowalski Martin Freeman Yang K. Chen Malcolm S. Branch Steven Edmundowicz Michael Gluck Kenneth Binmoeller Todd H. Baron Raj J. Shah Timothy Kinney William Ross Paul Jowell David Carr-Locke A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction Gastroenterology Research and Practice |
| title | A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction |
| title_full | A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction |
| title_fullStr | A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction |
| title_full_unstemmed | A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction |
| title_short | A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction |
| title_sort | multicenter prospective study of a new fully covered expandable metal biliary stent for the palliative treatment of malignant bile duct obstruction |
| url | http://dx.doi.org/10.1155/2013/642428 |
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