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Covered self-expandable metal stents (CSEMS) are often used for palliative endoscopic biliary drainage; however, the unobstructed period is limited because of sludge occlusion. The present study aimed to evaluate the biosafety of a novel poly(2-methoxyethyl acrylate)-coated CSEMS (PMEA-CSEMS) for sludge resistance and examine its biosafety in vivo. Using endoscopic retrograde cholangiopancreatography, we placed the PMEA-CSEMS into six normal porcine bile ducts and conventional CSEMS into three normal porcine bile ducts. We performed serological examination and undecalcified histological analysis at 1, 3, and 6 months during follow-up. In the bile ducts with PMEA-CSEMS or conventional CSEMS, we observed no increase in liver enzyme or inflammatory marker levels in the serological investigations and mild fibrosis but no inflammatory response in the histopathological analyses. Thus, we demonstrated the biosafety of PMEA-CSEMS in vivo.

The adhesion and deformation behavior of proteins at the inner surface of fully covered, self-expandable metallic stents coated with biocompatible polymers, poly(2-methoxyethyl acrylate) (PMEA) and poly(3-methoxypropyl acrylate) (PMC3A), were analyzed. Model bile solution, proteins, and bacteria were used to unravel the inhibitory ability of the polymer coatings. Adsorbance of proteins and adherence of bacteria were both strongly inhibited by the polymer coatings. Circulation tests were performed under clinical conditions using human bile from patients. Adsorption/deformation of proteins and early-stage sludge formation were inhibited on stent surfaces coated with PMEA derivatives. The present study revealed that early-stage biliary sludge formation on PMEA- and PMC3A-coated stents was suppressed due to the strong resistance of the polymers to protein adsorption/deformation, brought about by intermediate water in hydrated polymer coatings, which is not present in conventional coating materials, such as silicone and polyurethane.

Background Endoscopic double self-expandable metallic stent (SEMS) placement by the partial stent-in-stent (PSIS) method has been reported to be useful for the management of unresectable hilar malignant biliary obstruction. However, it is technically challenging, and the optimal SEMS for the procedure remains unknown. The aim of this study was to identify the risk factors for technical failure of endoscopic double SEMS placement for unresectable malignant hilar biliary obstruction (MHBO). Methods Between December 2009 and May 2013, 50 consecutive patients with MHBO underwent endoscopic double SEMS placement by the PSIS method. We retrospectively evaluated the rate of successful double SEMS placement and identified the risk factors for technical failure. Results The technical success rate for double SEMS placement was 82.0% (95% confidence interval [CI]: 69.2–90.2). On univariate analysis, the rate of technical failure was high in patients with metastatic disease and unilateral placement. Multivariate analysis revealed that metastatic disease was a significant risk factor for technical failure (odds ratio: 9.63, 95% CI: 1.11–105.5). The subgroup analysis after double guidewire insertion showed that the rate of technical success was higher in the laser-cut type SEMS with a large mesh and thick delivery system than in the braided type SEMS with a small mesh and thick delivery system. Conclusions Metastatic disease was a significant risk factor for technical failure of double SEMS placement for unresectable MHBO. The laser-cut type SEMS with a large mesh and thin delivery system might be preferable for the PSIS procedure.

Background Efforts to understand the properties of self-expandable metallic stents (SEMSs) through their mechanical properties have progressed. Among them, radial force (RF) is well known as an expanding force, but axial force (AF) has not been measured before. Correlations of these properties to clinical results are not well known. Objective We measured RF and AF of 14 different SEMSs and discussed the results in terms of clinical implications. Design Experimental study. Subjects Measurement of RF and AF of 14 different covered and uncovered SEMSs. Methods RF was measured with an RF measurement machine manufactured by Machine Solution, and AF was measured with in-house equipment. Results Measurements of RF in the process of expansion showed characteristic patterns closely related to the structures and materials of SEMSs. Results of AF measurement can be classified into 3 groups: high, medium, and low AF, depending on the type of SEMS. AF decreased with an increase of the length of stents. A plot of RF against AF revealed 3 distinguished RF/AF combinations and indicated the importance of understanding the properties by not only RF or AF individually but also by RF/AF combination. Limitations In vitro study using measurement equipment. Conclusion It was demonstrated that a combination of RF and AF is more effective than RF or AF individually in understanding the clinical implications of SEMSs. More work is needed to correlate mechanical properties with clinical results by designing model experiments.