What side effects are associated with this type of intervention?

Endoscopic laser resection, which involves laser ablation of stenotic tissue, can lead to side effects such as airway burns, scarring, and potential damage to surrounding tissues. Mechanical dilatation, which involves the widening of the trachea, may cause mucosal tears, bleeding, and the risk of restenosis due to the trauma inflicted on the tracheal walls. Both procedures carry a risk of infection and may require repeated treatments to maintain airway patency.

What prior FDA approvals exist?

The FDA has approved various devices and techniques for the treatment of tracheal stenosis, including endoscopic laser resection and mechanical dilatation. Endoscopic laser resection involves the use of laser technology to ablate stenotic tissue, while mechanical dilatation uses devices such as balloon catheters to widen the trachea. These procedures are commonly used to manage benign tracheal stenosis and have been shown to be effective in improving airway patency. Specific drugs are not typically involved in these mechanical and laser-based treatments, but supportive medications may be used to manage inflammation and prevent infection post-procedure.

What other types of research exist?

Promising novel alternatives for treating tracheal stenosis include: 1) Drug-eluting stents, which maintain airway patency while delivering localized medication to reduce inflammation and prevent restenosis. 2) Biodegradable stents, which provide temporary support and gradually dissolve, reducing the need for additional procedures. 3) Cryotherapy, which uses extreme cold to ablate stenotic tissue with minimal damage to surrounding structures. 4) Balloon dilation with adjunctive therapies, such as corticosteroid injections, to enhance the effectiveness and durability of the dilation.

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Procedure

Dilatation vs. Laser Resection for Tracheal Stenosis (AERATE Trial)

N/A

Recruiting

Led By Marc Fortin

Research Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Less than 18 years old

Incapacity to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods to treat a narrowed windpipe: using a laser to cut away the blockage or using a balloon to stretch it open. It focuses on patients with non-cancerous narrowing of the windpipe. The goal is to see which method works better for these patients.

Who is the study for?

This trial is for adults over 18 with a simple, benign tracheal stenosis that's less than 1cm long and without cartilage damage. It's open to those getting their first treatment or having a recurrence but not to individuals with inflammation-related conditions, those unable to consent, or pregnant women.

What is being tested?

The study compares two treatments for narrow airways due to benign tracheal stenosis: stretching the airway (dilatation) versus removing the blockage with a laser (endoscopic laser resection). Participants will be randomly assigned one of these treatments in multiple centers.

What are the potential side effects?

Possible side effects may include discomfort at the site of treatment, bleeding, risk of infection, temporary breathing difficulties post-procedure, and potential need for additional procedures if narrowing recurs.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Endoscopic laser resectionExperimental Treatment1 Intervention

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 II: DilatationExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endoscopic Laser Resection involves using a laser to precisely remove stenotic (narrowed) tissue from the trachea, which helps to clear the airway and improve breathing. This method is beneficial because it allows for targeted removal of the obstructive tissue with minimal damage to surrounding areas. Dilatation, on the other hand, involves mechanically widening the trachea using a balloon or other device to stretch the narrowed section. This method is important as it provides immediate relief by increasing the airway diameter, allowing for better airflow. Both treatments are crucial for tracheal stenosis patients as they directly address the airway obstruction, improving breathing and overall quality of life.