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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04674995
Other study ID # UModenaReggio18
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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