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

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

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

Study Overview

• Status: Recruiting
• Conditions: Tracheal Stenosis
• Intervention / Treatment: Procedure: Endoscopic laser resection; Procedure: Dilatation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Fortin; Phone Number: 5504 4186568711; Email: marc.fortin@criucpq.ulaval.ca

Study Locations

• Canada
  • Québec, Canada
    • Recruiting
    • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
    • Contact: Marc FORTIN; Email: marc.fortin@criucpq.ulaval.ca
    • Sub-Investigator: Thibaud SOUMAGNE
• France
  • Grenoble, France
    • Not yet recruiting
    • Centre Hospitalier Universitaire Grenoble Alpes
    • Contact: Ihab ATALLAH
  • Marseille, France
    • Not yet recruiting
    • Hopital Nord
    • Contact: Hervé DUTAU
  • Toulouse, France
    • Not yet recruiting
    • Hôpital Larrey, University Hospital of Toulouse
    • Contact: Nicolas Guibert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic laser resection; 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.	Procedure: Endoscopic laser resection; Laser resection
Experimental: Dilatation; Using a ballon or rigid bronchoscope the stenotic tracheal segment will be dilated with or without previous radial incision with electrocautery or laser.	Procedure: Dilatation; Dilatation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure	Within 2 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Investigators: Principal Investigator: Marc Fortin, Fondation IUCPQ

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pathological Conditions, Anatomical; Tracheal Diseases; Constriction, Pathologic; Tracheal Stenosis
• Other Study ID Numbers: 2021-3573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No