In this study, we used the covered metallic segmented airway stent to treat malignant strictures involving carina and bronchi distal to carina and aimed to determine the feasibility, efficacy and safety of this technique.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.
Ruijin Hospital Luwan Branch
Shanghai, China
RECRUITINGShanghai Tongren Hospital
Shanghai, China
RECRUITINGImprovement in Dyspnea using Hugh-Jones classication as criteria
Hugh-Jones classication: dyspnea scale that includes 5 categories.
Time frame: 3 days
Stent patency time
Stent patency time is defined as the time from the stent implantation to stent restenosis or death due to any cause, or censored at date last known alive.
Time frame: 2 months
Overall survival
OS is defined as the time from the stent implantation to death due to any cause, or censored at date last known alive.
Time frame: 6 months
Number of participants with adverse events that are related to stent implantation
Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion
Time frame: 2 months
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