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
About this trial
This is an interventional treatment trial for Tracheal Stenosis
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)
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
NCT ID
NCT04719845
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
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
Learn more about this trial
DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis
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