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

Not Applicable

• Conditions: Fistula, Gastric; Airway Disease; Fistula Bronchial
• Interventions: Procedure: Airway stent implantation

• Registration Number: NCT03890523
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-11
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Segmented Airway Stent for Gastro-Respiratory fistula	Airway stent implantation	Segmented covered metallic airway stent modified with 3D printing was used for gastro-respiratory fistula.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Shanghai Tongren Hospital; 🇨🇳 Shanghai, Shanghai, China

Ruijin Hospital Luwan Branch; 🇨🇳 Shanghai, China