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

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ClinicalTrials.gov Identifier: NCT04719845
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Marc Fortin, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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

Condition or disease Intervention/treatment Phase
Tracheal Stenosis Procedure: Endoscopic laser resection Procedure: Dilatation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dilatation Versus Endoscopic Laser Resection in Simple Benign Tracheal Stenosis : a Randomized Controlled Trial
Estimated Study Start Date : February 22, 2021
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Endoscopy

Arms and Interventions
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Arm Intervention/treatment
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
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
Dilatation


Outcome Measures
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Primary Outcome Measures :
  1. Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure [ Time Frame: Within 2 years ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719845


Contacts
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Contact: Marc Fortin 4186568711 ext 5504 marc.fortin@criucpq.ulaval.ca

Locations
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Canada
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) Recruiting
Québec, Canada
Contact: Marc FORTIN       marc.fortin@criucpq.ulaval.ca   
Sub-Investigator: Thibaud SOUMAGNE         
France
Centre Hospitalier Universitaire Grenoble Alpes Not yet recruiting
Grenoble, France
Contact: Ihab ATALLAH         
Hôpital Nord Not yet recruiting
Marseille, France
Contact: Hervé DUTAU         
Hôpital Larrey, University Hospital of Toulouse Not yet recruiting
Toulouse, France
Contact: Nicolas Guibert         
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Investigators
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Principal Investigator: Marc Fortin Fondation IUCPQ
More Information
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Responsible Party: Marc Fortin, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT04719845    
Other Study ID Numbers: 2021-3573
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tracheal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Tracheal Diseases
Respiratory Tract Diseases