Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

NCT ID: NCT04674995

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-01
• Study Completion Date: 2020-12-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Stent

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

Stent placement

Intervention Type: 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.

Balloon dilatation

Patients with tracheal stenosis treated with balloon dilatation via laryngoscope.

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Modena and Reggio Emilia

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Marchioni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UModenaReggio18

Identifier Type: -

Identifier Source: org_study_id