NCT04719845

DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

Dilatation Versus Endoscopic Laser Resection in Simple Benign Tracheal Stenosis : a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tracheal Stenosis

Interventions

Type	Name	Description
PROCEDURE	Endoscopic laser resection	Laser resection
PROCEDURE	Dilatation	Dilatation

Timeline

• Start date: 2021-03-17
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2021-01-22
• Last updated: 2022-05-03

Locations

4 sites across 2 countries: Canada, France