DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    108
  • sponsor
    Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Updated on 4 March 2021

Summary

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

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.

Details
Condition Tracheal Stenosis
Treatment Endoscopic laser resection, Dilatation, Dilatation
Clinical Study IdentifierNCT04719845
SponsorCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Last Modified on4 March 2021

Eligibility

Yes No Not Sure

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)
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