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Biodegradable polydioxanone stents in the treatment of adult patients with tracheal narrowing
L. Stehlik, V. Hytych, J. Letackova, P. Kubena, M. Vasakova,
Language English Country England, Great Britain
Document type Clinical Study, Journal Article, Research Support, Non-U.S. Gov't
Grant support
NT14146
MZ0
CEP Register
Digital library NLK
Full text - Article
Source
NLK
BioMedCentral
from 2001-12-01
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Directory of Open Access Journals
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- MeSH
- Biocompatible Materials chemistry MeSH
- Bronchoscopy MeSH
- Middle Aged MeSH
- Humans MeSH
- Polydioxanone chemistry MeSH
- Aged MeSH
- Tracheal Stenosis surgery MeSH
- Stents classification MeSH
- Trachea surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Czech Republic MeSH
BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: 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.
Department of Thoracic Surgery Thomayer Hospital Videnska 800 Prague 4 140 59 Czech Republic
ELLA CS Ltd Milady Horakove 504 45 Trebes 500 06 Hradec Kralove Czech Republic
References provided by Crossref.org
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- $a BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: 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.
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