Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study
Background and study aims: Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a ne...
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| Hauptverfasser: | , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
15.1.2015
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| In: |
Endoscopy
Year: 2015, Jahrgang: 47, Heft: 5, Pages: 430-436 |
| ISSN: | 1438-8812 |
| DOI: | 10.1055/s-0034-1391232 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1055/s-0034-1391232 Verlag, lizenzpflichtig, Volltext: http://www.thieme-connect.de/DOI/DOI?10.1055/s-0034-1391232 Verlag, Volltext: http://dx.doi.org/10.1055/s-0034-1391232 Verlag, Volltext: http://www.thieme-connect.de.ezproxy.medma.uni-heidelberg.de/DOI/DOI?10.1055/s-0034-1391232 
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| Verfasserangaben: | Authors Arthur Schmidt, Bettina Riecken, Susanne Rische, Christoph Klinger, Ralf Jakobs, Matthias Bechtler, Georg Kähler, Arno Dormann, Karel Caca |
MARC
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| 245 | 1 | 0 | |a Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction |b a randomized multicenter study |c Authors Arthur Schmidt, Bettina Riecken, Susanne Rische, Christoph Klinger, Ralf Jakobs, Matthias Bechtler, Georg Kähler, Arno Dormann, Karel Caca |
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| 520 | |a Background and study aims: Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. Patients and methods: A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS. Results: Stent failure occurred in 10/16 patients (62.5%) in the winged-stent group vs. 4/18 patients (22.2%) in the SEMS group (P=0.034). The median time to stent failure was 51 days (range 2–92 days) for the winged stent and 80 days (range 28–266 days) for the SEMS (P=0.002). Early stent failure (<8 weeks after placement) occurred in 8 patients (50%) vs. 2 patients (11.1%), respectively (P=0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns. Conclusions: The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. | ||
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| 700 | 1 | |a Jakobs, Ralf |e VerfasserIn |4 aut | |
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