Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04674995

Acronym

STROBE

Enrollment

Registered

2020-12-19

Start date

2012-11-01

Completion date

2020-12-01

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal Stenosis

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.

Interventions

PROCEDUREStent 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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026