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
- 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 μg/L (3 ppb) and 5 μg/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. (Clinical Research Information Service identifier: KCT 0002310.).
- All Author(s)
- T. H. Lee
; M. K. Jung
; T. K. Kim
; C. G. Pack
; Y. K. Park
; S. O. Kim
; D. H. Park
- Issued Date
- 2019
- Type
- Article
- Keyword
- Aged; Ampulla of Vater; Bile; *Biofilms; Carcinoma, Hepatocellular/complications; Cholangitis/epidemiology; Cholestasis/etiology/*surgery; Common Bile Duct Neoplasms/complications; Drainage/instrumentation; Endoscopy, Digestive System; Female; Gallbladder Neoplasms/complications; Humans; Liver Neoplasms/complications; Male; *Metal Nanoparticles; Microscopy, Electron, Scanning; Middle Aged; Palliative Care; Pancreatic Neoplasms/complications; Pancreatitis/epidemiology; Pilot Projects; Postoperative Complications/epidemiology; Prosthesis Failure; *Self Expandable Metallic Stents; *Silicones; *Silver
- Publisher
- American Society for Gastrointestinal Endoscopy
- ISSN
- 0016-5107
- Citation Title
- Gastrointestinal Endoscopy
- Citation Volume
- 90
- Citation Number
- 4
- Citation Start Page
- 663
- Citation End Page
- 672, e2
- Language(ISO)
- eng
- DOI
- 10.1016/j.gie.2019.06.007
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/2784
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