An interventional study of Airway stent implantation in Stricture; Trachea and Malignant Neoplasm, sponsored by Ruijin Hospital. Status unknown at 2 sites in China. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
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Exclusion Criteria:
Patients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing.
Procedure: Airway stent implantation
The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.
Improvement 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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital