Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

Study Overview
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Brief Summary
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This is a retrospective, observational cohort study carried out in two operative Units of the University Hospital of Modena (Italy): the Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B). The two units have different protocols routinely applied to treat tracheal benign stenosis. In Unit A, endoscopic treatment is performed through mechanical dilatation via rigid bronchoscopy and further stent placing while in Unit B the endoscopic treatment is performed through balloon dilatation via direct laryngoscopy. The primary purpose was to compare the efficacy of the two technique on tracheal stenosis treatment over time. Patients were defined as cured if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.

Official Title
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Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

Conditions
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Tracheal Stenosis

Intervention / Treatment
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* Procedure: Stent placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years, exclusion from resection-anastomosis surgery after multidisciplinary evaluation, Cotton Meyer > grade II, follow-up of at least 3 years after endoscopic surgery, no previous tracheal surgery. Exclusion Criteria: age > 80, stent intolerance which requires removal in the first year after endoscopic treatment, performance status > 2, end-stage chronic pulmonary disease, life-threatening stenosis that needs urgent endoscopic treatments, any neoplastic stenosis of the airways, dynamic etiology of tracheal benign stenosis (excessive dynamic airway collapse, tracheobronchomalacia).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stent<br>Patients with tracheal stenosis treated with stent placement via rigid bronchoscopy. | Procedure: Stent placement<br>* All interventional procedures have been performed in the operating room with a Dumon rigid bronchoscope under general anesthesia. Neodymium-doped yttrium aluminium garnet laser photoresection was performed at 15-30 watts and pulse duration of 0.5-1.0s whenever indicated. A silicone stent was placed.<br>|
| Balloon dilatation<br>Patients with tracheal stenosis treated with balloon dilatation via laryngoscope. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-stenosis rate over time | Patients were defined as cured if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability. | 36 months |