Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

NCT04674995 | Completed

• 1 other identifier: UModenaReggio18
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tracheal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Stent

Patients with tracheal stenosis treated with stent placement via rigid bronchoscopy.

Procedure: Stent placement

Balloon dilatation

Patients with tracheal stenosis treated with balloon dilatation via laryngoscope.

Interventions

Stent placement PROCEDURE

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.

Stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We collected clinical, endoscopic and radiological data of patients with benign tracheal stenosis admitted 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) from November 2012 to November 2017

You may qualify if:

• age \>18 years,
• Cotton Meyer \> grade II,
• follow-up of at least 3 years after endoscopic surgery,
• no previous tracheal surgery.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

MeSH Terms

Conditions

Tracheal Stenosis

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: November 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2020
• Last Updated: April 4, 2022

Record last verified: 2022-03