TY - JOUR
T1 - Biosafety of a novel covered self-expandable metal stent coated with poly(2-methoxyethyl acrylate) in vivo
AU - Ishizawa, Tetsuya
AU - Makino, Naohiko
AU - Kakizaki, Yasuharu
AU - Matsuda, Akiko
AU - Toyokawa, Yoshihide
AU - Ooyama, Shun
AU - Tanaka, Masaru
AU - Ueno, Yoshiyuki
N1 - Publisher Copyright:
© 2021 Ishizawa et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2021/9
Y1 - 2021/9
N2 - 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.
AB - 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.
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U2 - 10.1371/journal.pone.0257828
DO - 10.1371/journal.pone.0257828
M3 - Article
C2 - 34559849
AN - SCOPUS:85115785592
VL - 16
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 9 September
M1 - e0257828
ER -