DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

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

Detailed Description
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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.

Official Title
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Dilatation Versus Endoscopic Laser Resection in Simple Benign Tracheal Stenosis : a Randomized Controlled Trial

Conditions
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Tracheal Stenosis

Intervention / Treatment
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* Procedure: Endoscopic laser resection
* Procedure: Dilatation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic laser resection<br>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<br>* Laser resection<br>|
| Experimental: Dilatation<br>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<br>* Dilatation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure |  | Within 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate at 1 year of symptomatic tracheal stenosis (> 40%) requiring a new procedure |  | 1 year | 
| Time to first symptomatic relapse of tracheal stenosis |  | 2 years | 
| mMRC |  | 2 years | 
| VAS |  | 2 years | 
| Clinical COPD questionnaire |  | 2 years | 
| VHI-10 |  | 2 years | 
| SF-12 |  | 2 years | 
| Measurement of stenosis by cephalo-caudal length at endoscopic follow-up at 1 year |  | Within 2 years | 
| Rate of surgical resection following symptomatic recurrence |  | 2 years | 
| Rate and type of complications and adverse effects depending on the procedure |  | 2 years |