DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

NCT04719845 | Terminated

• 1 other identifier: 2021-3573
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Tracheal Stenosis

Outcome Measures

Primary Outcomes (1)

• Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure

  Within 2 years

Secondary Outcomes (10)

• 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

Other Outcomes (1)

• 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

Study Arms (2)

Endoscopic laser resection

EXPERIMENTAL

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

Dilatation

EXPERIMENTAL

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

Interventions

Endoscopic laser resection PROCEDURE

Laser resection

Endoscopic laser resection

Dilatation PROCEDURE

Dilatation

Dilatation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Benign simple tracheal stenosis (length of stenosis \<1cm without underlying cartilage damage) with planned endoscopic treatment (first treatment or recurrence)

You may not qualify if:

• Less than 18 years old
• Pregnant
• Incapacity to give informed consent
• Underlying inflammatory suspected to be the cause of stenosis (ex : granulomatosis with polyangitis)

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead

Study Sites (4)

Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Québec, Canada

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, France

Location

Hôpital Nord

Marseille, France

Location

Hôpital Larrey, University Hospital of Toulouse

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 35301206 DERIVED

MeSH Terms

Conditions

Tracheal Stenosis

Interventions

Dilatation

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Marc Fortin

  Fondation IUCPQ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: March 17, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 6, 2026

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); CA (1)