Endoscopy 2015; 47(05): 430-436
DOI: 10.1055/s-0034-1391232
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study

Arthur Schmidt
1   Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany
,
Bettina Riecken
1   Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany
,
Susanne Rische
1   Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany
,
Christoph Klinger
1   Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany
,
Ralf Jakobs
2   Department of Gastroenterology, Klinikum Ludwigshafen, Ludwigshafen, Germany
,
Matthias Bechtler
2   Department of Gastroenterology, Klinikum Ludwigshafen, Ludwigshafen, Germany
,
Georg Kähler
3   Department of Surgery, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany
,
Arno Dormann
4   Department of Medicine, Cologne City Hospital, Holweide, Cologne, Germany
,
Karel Caca
1   Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany
› Author Affiliations
Further Information

Publication History

submitted26 February 2014

accepted after revision11 November 2014

Publication Date:
15 January 2015 (online)

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.


Study registration ClinicalTrials.gov (NCT01063634).

 
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