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

Not Applicable

• Conditions: Stricture; Trachea; Malignant Neoplasm
• Interventions: Procedure: Airway stent implantation

• Registration Number: NCT03890575
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-11
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Airway Stent for Malignant Stricture	Airway stent implantation	Patients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing.

Primary Outcome Measures

Name	Time	Method
Improvement in Dyspnea using Hugh-Jones classication as criteria	3 days	Hugh-Jones classication: dyspnea scale that includes 5 categories.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Ruijin Hospital Luwan Branch; 🇨🇳 Shanghai, China

Shanghai Tongren Hospital; 🇨🇳 Shanghai, China