Airway fistula
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, regardless of gender; 2. A confirmed diagnosis of benign airway fistula based on fibreoptic bronchoscopy and/or imaging studies, including post-operative bronchial stump fistulae and benign tracheoesophageal fistulae; 3. Aistula orifice diameter <= 5 mm; 4. The orifice is visible and accessible under transbronchial endoscopy, making it suitable for submucosal injection around the orifice; 5. Participants who have already undergone, or are scheduled to undergo, endobronchial PRP therapy in accordance with the centre’s standard procedures under clinical decision-making; 6. Clinical records are relatively complete, and participants are able to cooperate with follow-up and re-evaluation examinations; 7. The participant and/or their legal representative has been informed and has signed the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Patients with confirmed malignant tumour infiltration of the fistula or adjacent areas, or those with a high suspicion of malignant lesions; 2. Patients with uncontrolled systemic infection or sepsis, haemodynamic instability, or those unsuitable for bronchoscopy in the short term; 3. Patients at significant risk of bleeding, such as those with severe coagulation disorders (marked prolongation of INR) or significantly reduced platelet counts, or those currently receiving dual antiplatelet or potent anticoagulant therapy that cannot be discontinued; 4. Patients with severe cardiac, pulmonary, hepatic or renal insufficiency who, following assessment, are deemed unable to tolerate sedation or bronchoscopy; 5. Pregnant or breastfeeding women; 6. Patients with other serious comorbidities that may affect the assessment of prognosis, or those deemed unsuitable for inclusion by the investigator; 7. Patients who refuse to sign the informed consent form or are unable to complete follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fistula closure rate at 3 months post-surgery, time to fistula closure, and improvement in symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Further intervention and referral situation;Improvement of symptoms associated with airway fistula;The closure status of the fistula at different time points;Fistula closure time; | — |
Countries
China
Contacts
Emergency General Hospital