Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

Completed

• Conditions: Tracheal Stenosis
• Interventions: Procedure: Stent placement

• Registration Number: NCT04674995
• Lead Sponsor: University of Modena and Reggio Emilia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-01
• Primary Completion: 2017-11-01
• Study Completion: 2020-12-01
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stent	Stent placement	Patients with tracheal stenosis treated with stent placement via rigid bronchoscopy.

Primary Outcome Measures

Name	Time	Method
Re-stenosis rate over time	36 months	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.