DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

Not Applicable

Recruiting

• Conditions: Tracheal Stenosis
• Interventions: Procedure: Endoscopic laser resection; Procedure: Dilatation

• Registration Number: NCT04719845
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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.

Study Timeline

• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-18
• Study First Posted: 2021-01-22
• Study Start: 2021-03-17
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-03
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic laser resection	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.
Dilatation	Dilatation	Using a ballon or rigid bronchoscope the stenotic tracheal segment will be dilated with or without previous radial incision with electrocautery or laser.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Centre Hospitalier Universitaire Grenoble Alpes; 🇫🇷 Grenoble, France

Hôpital Nord; 🇫🇷 Marseille, France

Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ); 🇨🇦 Québec, Canada

Hôpital Larrey, University Hospital of Toulouse; 🇫🇷 Toulouse, France