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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGRuijin Hospital Luwan Branch
Shanghai, China
RECRUITINGRelief of symptoms
Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.
Time frame: 1 month
Heal of fistula
The heal of fistula confirmed by gastroscopy, bronchoscopy and CT
Time frame: 3 months
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
Time frame: 6 months
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
Time frame: 6 months
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