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Biodegradable polydioxanone stents in the treatment of adult patients with tracheal narrowing

机译:可生物降解的聚二恶烷酮支架治疗成人气管狭窄患者

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Biodegradable stents that disintegrate after a period of time are expected to be well tolerated and have advantages over other stents that are more commonly used in practice today. Polydioxanone is a biodegradable polymer that is widely used during surgery with absorbable sutures. We present cases from the first four patients to undergo a tracheal polydioxanone stent insertion. Indications included significant non-malignant tracheal stenosis in cases where primary surgical treatment was not possible. The stents were implanted using rigid bronchoscopy and patients received regular follow-ups as needed. This use of biodegradable stents in adult patients was a novel, previously untested approach. The study was approved by the Institutional Ethics Committee and was based on a project entitled; “Biodegradable stents in the management of stenoses of large airways” (project NT 14146-3/2013). Six biodegradable stents were implanted in four patients with benign stenoses. No technical difficulties occurred and no serious or life-threatening events were recorded. All patients reported some benefit from treatment. Polydioxanone tracheal stents can be considered when a need for temporary support is expected, and as an alternative to other stents if the latter could compromise the patient. Owing to limited experience and observed disadvantages, further research is needed to fully assess this treatment. This work is based on project NT14146 - Biodegradable stents in the management of stenoses of the large airways (2013–2015, MZ0/NT), registered from May 1, 2013 in The Research and Development and Innovation Information System of the Czech Republic and in ClinicalTrials.gov, reg. no. NCT02620319 , December 2, 2015.
机译:一段时间后会崩解的可生物降解支架预计将具有良好的耐受性,并且比目前在实践中更常用的其他支架具有优势。聚二恶烷酮是一种可生物降解的聚合物,广泛用于具有可吸收缝线的手术中。我们介绍了从前四名患者接受气管聚二恶烷酮支架置入术的病例。适应症包括在不可能进行主要外科手术治疗的情况下的严重非恶性气管狭窄。使用刚性支气管镜植入支架,并根据需要对患者进行定期随访。在成年患者中这种可生物降解支架的使用是一种新颖的,未经测试的方法。该研究得到机构伦理委员会的批准,并基于一个名为; “大型气道狭窄管理中的可生物降解支架”(项目NT 14146-3 / 2013)。在四名良性狭窄患者中植入了六个可生物降解的支架。没有发生技术困难,也没有记录到严重或威胁生命的事件。所有患者均报告可从治疗中受益。当需要临时支撑时,可以考虑使用聚二恶烷气管支架,如果其他支架可能损害患者,则可以考虑使用聚二恶烷气管支架。由于经验有限和观察到的缺点,需要进一步研究以充分评估这种治疗。这项工作基于项目NT14146-大型气道狭窄的可生物降解支架管理(2013-2015,MZ0 / NT),该项目于2013年5月1日在捷克共和国的研发与创新信息系统中注册,并在ClinicalTrials.gov,reg。没有。 NCT02620319,2015年12月2日。

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