DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2025-03-01

Brief Summary

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

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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.

Conditions

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Tracheal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Endoscopic laser resection

Intervention Type PROCEDURE

Laser resection

Dilatation

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

Group Type EXPERIMENTAL

Dilatation

Intervention Type PROCEDURE

Dilatation

Interventions

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Endoscopic laser resection

Laser resection

Intervention Type PROCEDURE

Dilatation

Intervention Type PROCEDURE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No