Clinical trial NCT04719845: DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis
Official title: Dilatation Versus Endoscopic Laser Resection in Simple Benign Tracheal Stenosis : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheal Stenosis
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure
timeFrame: Within 2 years
Secondary outcomes:
measure: Relapse rate at 1 year of symptomatic tracheal stenosis (> 40%) requiring a new procedure
timeFrame: 1 year
measure: Time to first symptomatic relapse of tracheal stenosis
timeFrame: 2 years
measure: mMRC
timeFrame: 2 years
measure: VAS
timeFrame: 2 years
measure: Clinical COPD questionnaire
timeFrame: 2 years
measure: VHI-10
timeFrame: 2 years
measure: SF-12
timeFrame: 2 years
measure: Measurement of stenosis by cephalo-caudal length at endoscopic follow-up at 1 year
timeFrame: Within 2 years
measure: Rate of surgical resection following symptomatic recurrence
timeFrame: 2 years
measure: Rate and type of complications and adverse effects depending on the procedure
timeFrame: 2 years
Other outcomes:
measure: Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure in the idiopathic and non idiopathic subroup as well as in the first episode and recurrence subgroups
timeFrame: 2 years
Locations:
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: Marseille
country: France
facility: Hôpital Nord
city: Toulouse
country: France
facility: Hôpital Larrey, University Hospital of Toulouse
Study officials:
affiliation: Fondation IUCPQ
name: Marc Fortin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soumagne T, Guibert N, Atallah I, Lacasse Y, Dutau H, Fortin M. Dilation versus laser resection in subglottic stenosis: protocol for a prospective international multicentre randomised controlled trial (AERATE trial). BMJ Open. 2022 Mar 17;12(3):e053730. doi: 10.1136/bmjopen-2021-053730.