Abstract
Self-expanding metal stents (SEMSs) are preferred over plastic stents (PSs) in patients with life expectancy of >3 months. However, SEMSs for biliary application can become obstructed over time due to tumor overgrowth or ingrowth. Uncovered stents used for malignant obstructions in the biliary tree, especially in the hilar area, are prone to obstruction by tumor ingrowth. In comparison, full-covered stents may block bile duct branches and are at risk of migration. Moreover, metal stents merely promote biliary drainage and have no antitumor effect. In contrast, a drug-eluting self-expandable metallic stent (DES) may provide continuous tumor control and relief of malignant obstructive jaundice. In this study, a new design of SEMS was created and fabricated as advanced stent applications of material extrusion (ME) 3D printing for palliative treatment of unresectable malignant hilar biliary obstruction according to various paclitaxel (PTX)/poly ε-caprolactone (PCL) weight ratios. As a result, PTX-containing groups had significant effectiveness for inhibiting biliary tumor growth compared with the control group. The PTX-containing groups showed a controlled drug release profile, and its safety and efficacy were verified through in vivo testing. In conclusion, a new design of SEMS would be potential for palliative treatment of unresectable malignant hilar biliary obstruction.
Published Version
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