DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

Tracheal Stenosis Clinical Trial

— AERATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04719845
• Other study ID #: 2021-3573
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2022
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: Marc Fortin
• Phone: 4186568711
• Email: marc.fortin[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Constriction, Pathologic
• Tracheal Stenosis

Intervention

Procedure:
• Endoscopic laser resection
Laser resection
• Dilatation
Dilatation

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)	Québec
France	Centre Hospitalier Universitaire Grenoble Alpes	Grenoble
France	Hôpital Nord	Marseille
France	Hôpital Larrey, University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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		2 years
Primary	Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure		Within 2 years
Secondary	Relapse rate at 1 year of symptomatic tracheal stenosis (> 40%) requiring a new procedure		1 year
Secondary	Time to first symptomatic relapse of tracheal stenosis		2 years
Secondary	mMRC		2 years
Secondary	VAS		2 years
Secondary	Clinical COPD questionnaire		2 years
Secondary	VHI-10		2 years
Secondary	SF-12		2 years
Secondary	Measurement of stenosis by cephalo-caudal length at endoscopic follow-up at 1 year		Within 2 years
Secondary	Rate of surgical resection following symptomatic recurrence		2 years
Secondary	Rate and type of complications and adverse effects depending on the procedure		2 years