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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03890523

Enrollment

100

Registered

2019-03-26

Start date

2017-03-01

Completion date

2022-12-31

Last updated

2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Disease, Fistula Bronchial, Fistula, Gastric

Keywords

3D printed, airway stent, carina, distal bronchi

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.

Interventions

PROCEDUREAirway 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Relief of symptoms	1 month	Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.
Heal of fistula	3 months	The heal of fistula confirmed by gastroscopy, bronchoscopy and CT

Secondary

Measure	Time frame	Description
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
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

Countries

China

Contacts

Primary ContactZhongmin Wang, MD

wzm0722@hotmail.com0086-13901848333

Backup ContactQungang Shan, MD

qungangshan@sjtu.edu.cn0086-15989037568

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026