DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis (AERATE)

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Status: Enrolling

Conditions: Tracheal Stenosis

Treatments: Procedure: Endoscopic laser resection; Procedure: Dilatation

Study type: Interventional

Funder types: Other

Identifiers

NCT04719845

2021-3573

Details and patient eligibility

About

Multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

108 participants in 2 patient groups

Endoscopic laser resection

Experimental group

Description:

Using CO2, diode or similar wavelenght laser the stenotic tracheal segment will be vaporized allowing a less than 20% residual stenosis. Dilatation will not be performed after laser resection for residual stenosis.

Treatment:

Procedure: Endoscopic laser resection

Dilatation

Experimental group

Description:

Using a ballon or rigid bronchoscope the stenotic tracheal segment will be dilated with or without previous radial incision with electrocautery or laser.

Treatment:

Procedure: Dilatation