AzTrials
AzTrials

Tracheal StenosisAERATENCT04719845

DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

A study testing Endoscopic laser resection and Dilatation in people with Tracheal Stenosis, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tracheal Stenosis
What is being tested?
Endoscopic laser resection and Dilatation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
4 sitesin 2 countries
Study dates
17 Mar 2021to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

France3 sites

  • Centre Hospitalier Universitaire Grenoble Alpes

    Grenoble

  • Hôpital Nord

    Marseille

  • Hôpital Larrey, University Hospital of Toulouse

    Toulouse

Other trials in France

Canada1 site

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

    Québec

Other trials in Canada

About this study

Official title: 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.

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.

Being tested
Endoscopic laser resection, Dilatation
Medical subject headings
Tracheal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic laser resectionProcedure or surgery

    Laser resection

  • DilatationProcedure or surgery

    Dilatation

Study groups in NCT04719845
Study groupRoleWhat they receive
Endoscopic laser resectionExperimentalUsing 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.
Receives: Procedure: Endoscopic laser resection
DilatationExperimentalUsing a ballon or rigid bronchoscope the stenotic tracheal segment will be dilated with or without previous radial incision with electrocautery or laser.
Receives: Procedure: Dilatation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Within 2 years

Secondary outcomes (10)

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

    Measured: 1 year

  2. Time to first symptomatic relapse of tracheal stenosis

    Measured: 2 years

  3. mMRC

    Measured: 2 years

  4. VAS

    Measured: 2 years

  5. Clinical COPD questionnaire

    Measured: 2 years

  6. VHI-10

    Measured: 2 years

  7. SF-12

    Measured: 2 years

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

    Measured: Within 2 years

  9. Rate of surgical resection following symptomatic recurrence

    Measured: 2 years

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start17 Mar 2021
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Why it stopped: Excess of serious adverse events in the endoscopic laser resection group

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Single blind
Who is masked
Participant
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04719845
Sponsor's protocol ID
2021-3573
Acronym
AERATE
Status last verified
May 2022
First submitted
18 Jan 2021
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic laser resection and Dilatation in people with Tracheal Stenosis, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Excess of serious adverse events in the endoscopic laser resection group). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure (time frame: Within 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04719845, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in