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

Primary Purpose

Tracheal Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endoscopic laser resection
Dilatation
Sponsored by
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tracheal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)Recruiting
  • Centre Hospitalier Universitaire Grenoble Alpes
  • Hôpital Nord
  • Hôpital Larrey, University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Endoscopic laser resection

Dilatation

Arm Description

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.

Using a ballon or rigid bronchoscope the stenotic tracheal segment will be dilated with or without previous radial incision with electrocautery or laser.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 18, 2021
Last Updated
May 2, 2022
Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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1. Study Identification

Unique Protocol Identification Number
NCT04719845
Brief Title
DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis
Acronym
AERATE
Official Title
Dilatation Versus Endoscopic Laser Resection in Simple Benign Tracheal Stenosis : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Participant
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic laser resection
Arm Type
Experimental
Arm Description
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.
Arm Title
Dilatation
Arm Type
Experimental
Arm Description
Using a ballon or rigid bronchoscope the stenotic tracheal segment will be dilated with or without previous radial incision with electrocautery or laser.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic laser resection
Intervention Description
Laser resection
Intervention Type
Procedure
Intervention Name(s)
Dilatation
Intervention Description
Dilatation
Primary Outcome Measure Information:
Title
Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure
Time Frame
Within 2 years
Secondary Outcome Measure Information:
Title
Relapse rate at 1 year of symptomatic tracheal stenosis (> 40%) requiring a new procedure
Time Frame
1 year
Title
Time to first symptomatic relapse of tracheal stenosis
Time Frame
2 years
Title
mMRC
Time Frame
2 years
Title
VAS
Time Frame
2 years
Title
Clinical COPD questionnaire
Time Frame
2 years
Title
VHI-10
Time Frame
2 years
Title
SF-12
Time Frame
2 years
Title
Measurement of stenosis by cephalo-caudal length at endoscopic follow-up at 1 year
Time Frame
Within 2 years
Title
Rate of surgical resection following symptomatic recurrence
Time Frame
2 years
Title
Rate and type of complications and adverse effects depending on the procedure
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Fortin
Phone
4186568711
Ext
5504
Email
marc.fortin@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Fortin
Organizational Affiliation
Fondation IUCPQ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
City
Québec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc FORTIN
Email
marc.fortin@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Thibaud SOUMAGNE
Facility Name
Centre Hospitalier Universitaire Grenoble Alpes
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ihab ATALLAH
Facility Name
Hôpital Nord
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé DUTAU
Facility Name
Hôpital Larrey, University Hospital of Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Guibert

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35301206
Citation
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.
Results Reference
derived

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DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

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