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TerminatedNCT04719845AERATEUpdated May 6, 2026

DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

An interventional study of Endoscopic laser resection and Dilatation in Tracheal Stenosis, sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec. Terminated at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Not applicable, Interventional, and Treatment

Why this study was terminated
Excess of serious adverse events in the endoscopic laser resection group
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Tracheal Stenosis

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03

In context

Tracheal Stenosis

37 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.

This study's enrollment of 108 is above the median of 22 across 22 interventional studies indexed under Tracheal Stenosis.

Browse Tracheal Stenosis studies →

Lead sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
108 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureEndoscopic laser resection

    Laser resection

  • ProcedureDilatation

    Dilatation

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What researchers measure

Primary outcomes

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

    Time frame: Within 2 years

Secondary outcomes

  1. Relapse rate at 1 year of symptomatic tracheal stenosis (> 40%) requiring a new procedure

    Time frame: 1 year

  2. Time to first symptomatic relapse of tracheal stenosis

    Time frame: 2 years

  3. mMRC

    Time frame: 2 years

  4. VAS

    Time frame: 2 years

  5. Clinical COPD questionnaire

    Time frame: 2 years

  6. VHI-10

    Time frame: 2 years

  7. SF-12

    Time frame: 2 years

  8. Measurement of stenosis by cephalo-caudal length at endoscopic follow-up at 1 year

    Time frame: Within 2 years

  9. Rate of surgical resection following symptomatic recurrence

    Time frame: 2 years

  10. Rate and type of complications and adverse effects depending on the procedure

    Time frame: 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

    Time frame: 2 years

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Study locations

4 sites
  • Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
    Québec, Canada
  • Centre Hospitalier Universitaire Grenoble Alpes
    Grenoble, France
  • Hôpital Nord
    Marseille, France
  • Hôpital Larrey, University Hospital of Toulouse
    Toulouse, France
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References and documents

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. PubMed 35301206 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04719845
Lead sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Responsible party
Marc Fortin (MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec) — Principal investigator
First posted
Jan 22, 2021
Start date
Mar 17, 2021
Primary completion
Nov 1, 2022
Completion
Nov 1, 2022
Last update
May 6, 2026

Study contacts

Marc Fortin
principal investigator · Fondation IUCPQ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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