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

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ClinicalTrials.gov Identifier: NCT03890575
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : February 11, 2020
Sponsor:
Collaborators:
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai Tong Ren Hospital
Ruijin Hospital Luwan Branch
Information provided by (Responsible Party):
Zhongmin Wang, 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.

Condition or disease Intervention/treatment Phase
Stricture; Trachea Malignant Neoplasm Procedure: Airway stent implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Airway Stent for Malignant Stricture
Patients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing.
Procedure: Airway stent implantation
The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.




Primary Outcome Measures :
  1. Improvement in Dyspnea using Hugh-Jones classication as criteria [ Time Frame: 3 days ]
    Hugh-Jones classication: dyspnea scale that includes 5 categories.

  2. 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.

  3. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890575


Contacts
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Contact: Zhongmin Wang, MD 0086-13901848333 wzm0722@hotmail.com
Contact: Qungang Shan, MD 0086-15989037568 qungangshan@sjtu.edu.cn

Locations
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China
Ruijin Hospital Luwan Branch Recruiting
Shanghai, China
Contact: Ju Gong         
Shanghai Tongren Hospital Recruiting
Shanghai, China
Contact: Aiwu Mao         
Sponsors and Collaborators
Ruijin Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai Tong Ren Hospital
Ruijin Hospital Luwan Branch
Investigators
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Principal Investigator: Zhongmin Wang, MD Ruijin Hospital
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Responsible Party: Zhongmin Wang, Principal Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03890575    
Other Study ID Numbers: malignantairwaystent
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhongmin Wang, Ruijin Hospital:
3D printed
airway stent
carina
distal bronchi
Additional relevant MeSH terms:
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Neoplasms
Tracheal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Tracheal Diseases
Respiratory Tract Diseases