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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 1, 2022

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Airway Stent for Malignant Stricture
    • Patients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Number of participants with adverse events that are related to stent implantation
    • Time Frame: 2 months
    • Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ruijin Hospital
  • Collaborator
    • Shanghai Pulmonary Hospital, Shanghai, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhongmin Wang, Principal Investigator – Ruijin Hospital
  • Overall Official(s)
    • Zhongmin Wang, MD, Principal Investigator, Ruijin Hospital
  • Overall Contact(s)
    • Zhongmin Wang, MD, 0086-13901848333, wzm0722@hotmail.com

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