Excess of serious adverse events in the endoscopic laser resection group

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.

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)