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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Fistula Bronchial; Airway Disease; Fistula, Gastric

Treatments: Procedure: Airway stent implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03890523

airwaystentfistula

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Segmented Airway Stent for Gastro-Respiratory fistula

Experimental group

Description:

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

Treatment:

Procedure: Airway stent implantation