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

Airway Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03890523
• Other study ID #: airwaystentfistula
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2020
• Source: Ruijin Hospital
• Contact: Zhongmin Wang, MD
• Phone: 0086-13901848333
• Email: wzm0722[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Disease
• Fistula
• Fistula Bronchial
• Fistula, Gastric
• Gastric Fistula

Intervention

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.

Locations

Country	Name	City	State
China	Ruijin Hospital Luwan Branch	Shanghai
China	Shanghai Tongren Hospital	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Ruijin Hospital	Ruijin Hospital Luwan Branch, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Tong Ren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of symptoms	Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.	1 month
Primary	Heal of fistula	The heal of fistula confirmed by gastroscopy, bronchoscopy and CT	3 months
Secondary	Number of participants with adverse events that are related to stent implantation	Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion	6 months
Secondary	Stent patency time	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	6 months