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Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03890523
Collaborator
Shanghai Pulmonary Hospital, Shanghai, China (Other), Shanghai Tong Ren Hospital (Other), Ruijin Hospital Luwan Branch (Other)
100
Enrollment
2
Locations
1
Arm
70
Anticipated Duration (Months)
50
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the investigators used the covered metallic segmented airway stent modified with 3D printing to treat gastro-respiratory fistula involving carina and distal bronchi and aimed to determine the feasibility, efficacy and safety of this technique.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Airway stent implantation
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 Gastro-respiratory Fistula Involving Carina and Distal Bronchi
Actual Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Segmented Airway Stent for Gastro-Respiratory fistula

Segmented covered metallic airway stent modified with 3D printing was used for gastro-respiratory fistula.

Procedure: Airway stent implantation
The segmented airway stent modified with 3D printing were implanted to treat gastro-respiratory fistula involving carina and distal bronchi. The stents were removed because of stent-related complications or tracheobronchial healing.
Other Names:
  • Stent removal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Relief of symptoms [1 month]

      Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.

    2. Heal of fistula [3 months]

      The heal of fistula confirmed by gastroscopy, bronchoscopy and CT

    Secondary Outcome Measures

    1. Number of participants with adverse events that are related to stent implantation [6 months]

      Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion

    2. Stent patency time [6 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with gastro-respiratory fistula involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy , gastroscopy and CT.

    • The patients who could not tolerate surgery and did not have clinical improvement after conservative treatment.

    Exclusion Criteria:

    • Severe infection

    • coagulation disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Tongren Hospital Shanghai Shanghai China
    2 Ruijin Hospital Luwan Branch Shanghai China

    Sponsors and Collaborators

    • Ruijin Hospital
    • Shanghai Pulmonary Hospital, Shanghai, China
    • Shanghai Tong Ren Hospital
    • Ruijin Hospital Luwan Branch

    Investigators

    • Principal Investigator: Zhongmin Wang, MD, Ruijin Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongmin Wang, Principal Investigator, Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT03890523
    Other Study ID Numbers:
    • airwaystentfistula
    First Posted:
    Mar 26, 2019
    Last Update Posted:
    Feb 11, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhongmin Wang, Principal Investigator, Ruijin Hospital
    3D printed
    airway stent
    carina
    distal bronchi
    Additional relevant MeSH terms:
    Gastric Fistula
    Fistula

    Study Results

    No Results Posted as of Feb 11, 2020