Multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
Laser resection
Dilatation
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Canada
RECRUITINGCentre Hospitalier Universitaire Grenoble Alpes
Grenoble, France
NOT_YET_RECRUITINGHôpital Nord
Marseille, France
NOT_YET_RECRUITINGRelapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure
Time frame: Within 2 years
Relapse rate at 1 year of symptomatic tracheal stenosis (> 40%) requiring a new procedure
Time frame: 1 year
Time to first symptomatic relapse of tracheal stenosis
Time frame: 2 years
mMRC
Time frame: 2 years
VAS
Time frame: 2 years
Clinical COPD questionnaire
Time frame: 2 years
VHI-10
Time frame: 2 years
SF-12
Time frame: 2 years
Measurement of stenosis by cephalo-caudal length at endoscopic follow-up at 1 year
Time frame: Within 2 years
Rate of surgical resection following symptomatic recurrence
Time frame: 2 years
Rate and type of complications and adverse effects depending on the procedure
Time frame: 2 years
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Hôpital Larrey, University Hospital of Toulouse
Toulouse, France
NOT_YET_RECRUITING