Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

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.

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Key information

Conditions

Tracheal Stenosis Respiratory Tract Diseases Tracheal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

Re-stenosis rate over time

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Acronym: STROBE

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2020
First posted: Dec 19, 2020
Registry last updated: Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed