Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stricture; Trachea
- Sponsor
- Ruijin Hospital
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Improvement in Dyspnea using Hugh-Jones classication as criteria
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Zhongmin Wang
Principal Investigator
Ruijin Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with malignant stricture involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy or CT.
Exclusion Criteria
- •Severe infection
- •Coagulation disorders
Outcomes
Primary Outcomes
Improvement in Dyspnea using Hugh-Jones classication as criteria
Time Frame: 3 days
Hugh-Jones classication: dyspnea scale that includes 5 categories.
Overall survival
Time Frame: 6 months
OS is defined as the time from the stent implantation to death due to any cause, or censored at date last known alive.
Stent patency time
Time Frame: 2 months
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.
Secondary Outcomes
- Number of participants with adverse events that are related to stent implantation(2 months)