Malignant Neoplasm, Stricture; Trachea
Conditions
Keywords
3D printed, airway stent, carina, distal bronchi
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.
Interventions
PROCEDUREAirway stent implantation
The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai Tong Ren Hospital
Ruijin Hospital Luwan Branch
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Dyspnea using Hugh-Jones classication as criteria | 3 days | Hugh-Jones classication: dyspnea scale that includes 5 categories. |
| Stent patency time | 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. |
| Overall survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events that are related to stent implantation | 2 months | Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion |
Countries
China
Contacts
Primary ContactZhongmin Wang, MD
Backup ContactQungang Shan, MD
Outcome results
None listed