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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890523
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, 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
Airway Disease Fistula Bronchial Fistula, Gastric 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 Gastro-respiratory Fistula Involving Carina and Distal Bronchi
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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 Name: Stent removal




Primary Outcome Measures :
  1. Relief of symptoms [ Time Frame: 1 month ]
    Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.

  2. Heal of fistula [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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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 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

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): NCT03890523


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, Shanghai
Shanghai Tongren Hospital Recruiting
Shanghai, Shanghai, China
Contact: Aiwu Mao, MD         
China
Ruijin Hospital Luwan Branch Recruiting
Shanghai, China
Contact: Ju Gong         
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: NCT03890523    
Other Study ID Numbers: airwaystentfistula
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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Gastric Fistula
Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases