1. Drug-eluting fully covered self-expanding metal stent for dissolution of bile duct stones in vitro .
- Author
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Huang C, Cai XB, Guo LL, Qi XS, Gao Q, and Wan XJ
- Subjects
- Alloys, Animals, Common Bile Duct, Disease Models, Animal, Drug Carriers chemistry, Drug Liberation, Edetic Acid pharmacokinetics, Humans, Male, Nanofibers, Polyesters chemistry, Sodium Cholate pharmacokinetics, Swine, Swine, Miniature, Treatment Outcome, Drug-Eluting Stents, Edetic Acid administration & dosage, Gallstones therapy, Self Expandable Metallic Stents, Sodium Cholate administration & dosage
- Abstract
Background: The treatment of difficult common bile duct stones (CBDS) remains a big challenge around the world. Biliary stenting is a widely accepted rescue method in patients with failed stone extraction under endoscopic retrograde cholangiopancreatography. Fully covered self-expanding metal stent (FCSEMS) has gained increasing attention in the management of difficult CBDS., Aim: To manufacture a drug-eluting FCSEMS, which can achieve controlled release of stone-dissolving agents and speed up the dissolution of CBDS., Methods: Customized covered nitinol stents were adopted. Sodium cholate (SC) and disodium ethylene diamine tetraacetic acid (EDTA disodium, EDTA for short) were used as stone-dissolving agents. Three different types of drug-eluting stents were manufactured by dip coating (Stent I), coaxial electrospinning (Stent II), and dip coating combined with electrospinning (Stent III), respectively. The drug-release behavior and stone-dissolving efficacy of these stents were evaluated in vitro to sort out the best manufacturing method. And the selected stone-dissolving stents were further put into porcine CBD to evaluate their biosecurity., Results: Stent I and Stent II had obvious burst release of drugs in the first 5 d while Stent III presented controlled and sustainable drug release for 30 d. In still buffer, the final stone mass-loss rate of each group was 5.19% ± 0.69% for naked FCSEMS, 20.37% ± 2.13% for Stent I, 24.57% ± 1.45% for Stent II, and 33.72% ± 0.67% for Stent III. In flowing bile, the final stone mass-loss rate of each group was 5.87% ± 0.25% for naked FCSEMS, 6.36% ± 0.48% for Stent I, 6.38% ± 0.37% for Stent II, and 8.15% ± 0.27% for Stent III. Stent III caused the most stone mass-loss no matter in still buffer or in flowing bile, which was significantly higher than those of other groups ( P < 0.05). In vivo , Stent III made no difference from naked FCSEMS in serological analysis ( P > 0.05) and histopathological examination ( P > 0.05)., Conclusion: The novel SC and EDTA-eluting FCSEMS is efficient in diminishing CBDS in vitro . When conventional endoscopic techniques fail to remove difficult CBDS, SC and EDTA-eluting FCSEMS implantation may be considered a promising alternative., Competing Interests: Conflict-of-interest statement: All authors declare no conflicts of interest related to this article.
- Published
- 2019
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