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| Name | Class |
|---|---|
| Shanghai Pulmonary Hospital, Shanghai, China | OTHER |
| Shanghai Tong Ren Hospital | OTHER |
| Ruijin Hospital Luwan Branch | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Segmented Airway Stent for Gastro-Respiratory fistula | Experimental | Segmented covered metallic airway stent modified with 3D printing was used for gastro-respiratory fistula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airway stent implantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relief of symptoms | Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration. | 1 month |
| Heal of fistula | The heal of fistula confirmed by gastroscopy, bronchoscopy and CT | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Stent patency time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongmin Wang, MD | Contact | 0086-13901848333 | wzm0722@hotmail.com | |
| Qungang Shan, MD | Contact | 0086-15989037568 | qungangshan@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhongmin Wang, MD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tongren Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D001983 | Bronchial Fistula |
| D005747 | Gastric Fistula |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D016156 | Respiratory Tract Fistula |
| D005402 | Fistula |
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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 |
| Ruijin Hospital Luwan Branch | Recruiting | Shanghai | China |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |