Airway Segmented Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Distal Bronchi

Malignant Neoplasm Clinical Trial

Official title:

Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03890575
• Other study ID #: malignantairwaystent
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2020
• Source: Ruijin Hospital
• Contact: Zhongmin Wang, MD
• Phone: 0086-13901848333
• Email: wzm0722[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Malignant Neoplasm
• Neoplasms
• Stricture; Trachea
• Tracheal Stenosis

Intervention

Procedure:
• Airway stent implantation
The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.

Locations

Country	Name	City	State
China	Ruijin Hospital Luwan Branch	Shanghai
China	Shanghai Tongren Hospital	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Ruijin Hospital	Ruijin Hospital Luwan Branch, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Tong Ren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Dyspnea using Hugh-Jones classication as criteria	Hugh-Jones classication: dyspnea scale that includes 5 categories.	3 days
Primary	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.	2 months
Primary	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.	6 months
Secondary	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	2 months