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Gastrointest Endosc. 2019 Jun 17. pii: S0016-5107(19)31952-2. doi: 10.1016/j.gie.2019.06.007. [Epub ahead of print]

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: Phase II pilot study.

Author information

1
Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, South Korea.
2
Asan Institute for Life Sciences, Asan Medical Center and Department of Convergence Medicine, University of Ulsan College of Medicine, Seoul, South Korea; Department of Structure and Function of Neural Network, Korea Brain Research Institute, Daegu, South Korea.
3
Asan Institute for Life Sciences, Asan Medical Center and Department of Convergence Medicine, University of Ulsan College of Medicine, Seoul, South Korea.
4
Division of Gastroenterology, Asan Institute for Life Sciences, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
5
Department of Clinical Epidemiology and Biostatistics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
6
Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. Electronic address: dhpark@amc.seoul.kr.

Abstract

BACKGROUND AND AIMS:

Membrane-covered self-expandable metal stents (SEMSs) have been developed to prolong patency of stents by reducing tissue hyperplasia or tumor ingrowth. However, their effectiveness is attenuated by stent clogging due to biofilm formation on the inner covering surface of membrane. This pilot study planned 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 due to 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% (22/24), respectively. The rates of early and late adverse events were 22.7% and 36.4%, respectively. The primary reintervention rate was 27.3% (6/22). Only one 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:

SEMS covered with a silicone membrane containing integrated Ag-Ps may be effective and safe in malignant distal biliary obstruction. Sludge-impaction-related stent dysfunction may be less frequent using this new stent (cris.nih.go.kr, Identifier: KCT 0002310).

KEYWORDS:

Biliary obstruction; covered; endoscopic drainage; metal stent; silver particle

PMID:
31220446
DOI:
10.1016/j.gie.2019.06.007

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