Benign esophageal tracheal fistulas
Conditions
Interventions
Intervention Group:Placement of the composite stent
Sponsors
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients aged 18–80 years: 1. Diagnosed with upper gastrointestinal-tracheal fistula; 2. Enhanced conservative management or routine endoscopic treatment has failed, with unwillingness or inability to tolerate surgery; 3. Fistula diameter of 6–20 mm; 4. Tracheal side of the fistula is located in the middle or lower trachea, or within 2 cm of the carina on the main bronchus.
Exclusion criteria
Exclusion criteria: 1. Localised ulceration; 2. Coagulopathy (International Normalised Ratio > 1.5 or platelet count < 50,000/mm³ or undergoing antithrombotic therapy); 3. Severe cardiovascular or cerebrovascular disease (unstable angina pectoris, myocardial infarction, heart failure, cerebrovascular accident, or transient ischaemic attack within the preceding six months); 4. History of psychiatric disorders; 5. Active psychiatric illness; 6. Pregnancy; 7. Intolerance to general anaesthesia; 8. Glottic stenosis; 9. Uncontrolled airway mucosal inflammation (e.g., tuberculosis), distal airway obstruction, or associated atelectasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of device related adverse events;Rate of complete endoscopic occlusion;Clinical effectiveness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Rate of incomplete endoscopic closure;body mass index (BMI);Short Form 36 Health Survey; | — |
Countries
China
Contacts
Public ContactGuoxin Zhang
The First Affiliated Hospital of Nanjing Medical University(Jiangsu Provincial People's Hospital)
Outcome results
None listed