Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

Tracheal Stenosis Clinical Trial

— STROBE  

Official title:

Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674995
• Other study ID #: UModenaReggio18
• Status: Completed
• Start date: November 1, 2012
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2022
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 1, 2020
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Constriction, Pathologic
• Tracheal Stenosis

Intervention

Procedure:
• Stent placement
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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