Tracheal Stenosis
Conditions
Brief summary
Multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis.
Detailed description
An observational study suggests the superiority of endoscopic laser resection over dilatation in idiopathic tracheal stenosis but little litterature has been published on the subject. Hence we decided to design a prospective multicenter open label randomized controlled trial to compare the two interventions. Patients refered for endoscopic treatment of a simple benign tracheal stenosis will be randomized to endoscopic laser resection or dilatation. Randomisation will be stratified for center, type of stenosis (idiopathic vs other) and history of previous endoscopic treatment. Patients will be blinded to treatment but not physician. All patients will be treated with proton pump inhibitors.
Interventions
PROCEDUREEndoscopic laser resection
Laser resection
PROCEDUREDilatation
Dilatation
Sponsors
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Benign simple tracheal stenosis (length of stenosis \<1cm without underlying cartilage damage) with planned endoscopic treatment (first treatment or recurrence)
Exclusion criteria
* Less than 18 years old * Pregnant * Incapacity to give informed consent * Underlying inflammatory suspected to be the cause of stenosis (ex : granulomatosis with polyangitis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure | Within 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Relapse rate at 1 year of symptomatic tracheal stenosis (> 40%) requiring a new procedure | 1 year |
| Time to first symptomatic relapse of tracheal stenosis | 2 years |
| mMRC | 2 years |
| VAS | 2 years |
| Clinical COPD questionnaire | 2 years |
| VHI-10 | 2 years |
| SF-12 | 2 years |
| Measurement of stenosis by cephalo-caudal length at endoscopic follow-up at 1 year | Within 2 years |
| Rate of surgical resection following symptomatic recurrence | 2 years |
| Rate and type of complications and adverse effects depending on the procedure | 2 years |
Countries
Canada, France
Contacts
PRINCIPAL_INVESTIGATORMarc Fortin
Fondation IUCPQ
Outcome results
None listed