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Cited 10 time in webofscience Cited 12 time in scopus
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Safety and efficacy of a metal stent covered with a silicone membrane containing integrated silver particles in preventing biofilm and sludge formation in endoscopic drainage of malignant biliary obstruction: a phase 2 pilot study

Authors
Lee, Tae HoonJung, Min KyoKim, Tae-KeunPack, Chan GiPark, Yoon KyungKim, Seon-OkPark, Do Hyun
Issue Date
Oct-2019
Publisher
MOSBY-ELSEVIER
Citation
GASTROINTESTINAL ENDOSCOPY, v.90, no.4, pp.663 - +
Journal Title
GASTROINTESTINAL ENDOSCOPY
Volume
90
Number
4
Start Page
663
End Page
+
URI
http://scholarworks.bwise.kr/kbri/handle/2023.sw.kbri/666
DOI
10.1016/j.gie.2019.06.007
ISSN
0016-5107
Abstract
Background and Aims: Membrane-covered self-expandable metal stents (SEMSs) have been developed to prolong the patency of stents by reducing tissue hyperplasia or tumor ingrowth. However, their effectiveness is attenuated by stent clogging as a result of biofilm formation on the inner surface of the membrane. The aim of this pilot study was to evaluate the efficacy and safety of SEMSs covered with a silicone membrane containing integrated silver particles (Ag-P) in malignant distal biliary obstruction. Methods: Twenty-four patients who underwent SEMS placement because of malignant distal biliary obstruction were enrolled in this single-center pilot study. The main outcomes were technical success, clinical success, adverse events, stent patency, and survival. Results: The technical and clinical success rates were 100% and 91.7% (22 of 24), respectively. The rates of early and late adverse events were 22.7% and 36.4%, respectively. The primary reintervention rate was 27.3% (6 of 22). Only 1 case involving stent malfunction was associated with sludge impaction. Median stent patency was 179 days. During follow-up, there were no serious adverse events or mortality related to the stents or Ag-P. Serum and urine silver concentrations before and after stent placement and at 32 weeks after placement did not differ. All serum and urine silver concentrations were <3 mu g/L (3 ppb) and 5 mu g/L (5 ppb), respectively. Conclusions: SEMSs covered with a silicone membrane containing integrated Ag-Ps may be effective and safe in malignant distal biliary obstruction. Stent dysfunction related to sludge impaction may be less frequent using this new stent.
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