Dilatation vs. Laser Resection for Tracheal Stenosis

(AERATE Trial)

Recruiting at3 trial locations

Overseen by Marc Fortin

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Dilatation vs. Laser Resection for Tracheal Stenosis is an effective treatment?

The available research shows that endoscopic CO2-laser resection can improve airway size to nearly normal in a significant number of patients with less severe tracheal stenosis. For grade I stenosis, 92% of patients achieved a nearly normal airway, while for grade II, 46% saw improvement. However, for more severe cases, open surgery was more effective, with 76% of patients achieving normal breathing compared to 36% in the endoscopy group. Endoscopic treatment is less invasive and requires a shorter hospital stay, making it a worthwhile first option for selected patients with less severe stenosis. ^{1 2 3 4 5}

What safety data exists for dilatation and laser resection in treating tracheal stenosis?

The safety data for dilatation and laser resection in treating tracheal stenosis includes several findings: Endoscopic CO2-laser resection is less invasive and risky compared to open surgery, with a short hospital stay, but its effectiveness decreases with more severe stenosis grades. A study of 100 cases showed that endoscopic treatment improved airway size significantly in grade I and II stenoses, but less so in grade III. Another study highlighted the risk of respiratory arrest due to delayed tissue edema after laser treatment. Balloon dilatation and stenting are alternative endoscopic techniques, with a study comparing their efficacy and adverse event rates. Additionally, combining dilation with laser therapy and mitomycin-C application has been reported as successful in some cases. ^{1 4 6 7 8}

Is Dilatation, Endoscopic laser resection a promising treatment for tracheal stenosis?

Yes, Dilatation and Endoscopic laser resection are promising treatments for tracheal stenosis. They can improve symptoms and quality of life, especially for patients who are not suitable for surgery. These methods are effective in managing tracheal stenosis and have been successfully used in various cases. ^{1 2 5 9 10}

Research Team

Marc Fortin

Principal Investigator

Fondation IUCPQ

Eligibility Criteria

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.

Inclusion Criteria

I have a small, non-cancerous narrowing in my windpipe and am planning to have a procedure to open it.

Exclusion Criteria

I am under 18 years old.

I am unable to understand and give consent for treatment.

My narrowing of passages is due to inflammation, possibly from a condition like granulomatosis with polyangiitis.

Treatment Details

Interventions

• Dilatation (Procedure)
• Endoscopic laser resection (Procedure)

Trial Overview 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.

Participant Groups

Group I: Endoscopic laser resection Experimental Treatment 1 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: Dilatation Experimental Treatment 1 Intervention

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

Dilatation is already approved in Canada for the following indications:

Approved in Canada as Airway dilation for:

• Benign tracheal stenosis

Who Is Running the Clinical Trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Lead Sponsor

Trials

37

Recruited

9,700+

Findings from Research

Segmental resection and reconstruction with end-to-end anastomosis is the most effective treatment for tracheal stenosis, with a high success rate of uncomplicated healing in 91.8% of patients from a study of 110 cases.

The 30-day mortality rate was low at 0.9%, and 93.5% of patients reported satisfaction with the surgical outcome, indicating that this method is both safe and effective for managing tracheal stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results after 110 tracheal resections. Friedel, G., Kyriss, T., Leitenberger, A., et al.[2021]

A novel treatment method using a percutaneous tracheostomy dilator was successfully employed to dilate symptomatic tracheal stenosis when other methods, like rigid bronchoscopic dilation and balloon dilation, had failed.

This approach offers a new option for patients with posttracheostomy tracheal stenosis, which is a rare but serious complication of prolonged tracheal intubation, highlighting the need for innovative solutions in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fiberoptic-Guided Blue Rhino Dilator-Assisted Dilation of Postintubation Tracheal Stenosis: A Case Report About a Novel Technique. Gupta, N., Sahoo, P., Madan, K., et al.[2017]

A novel technique for tracheobronchial dilatation using a non-occlusive balloon through a supraglottic airway device allows for continuous ventilation and endoscopic guidance, enhancing safety during the procedure.

This method has proven to be effective in managing tracheal stenosis, avoiding the need for emergency tracheostomy, and can be performed reliably by junior staff after proper training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How we do it: endoscopic tracheal dilatation technique using a supraglottic airway device and non-occlusive balloon. Hofmeyr, R., Lubbe, D.[2023]

Endoscopic CO2-laser resection is effective for treating benign laryngotracheal stenosis (LTS), with 92% improvement in grade I cases, but lower success rates for grade II (46%) and grade III (13%) stenoses, based on a review of 100 patients.

While endoscopic treatment is less invasive and allows for shorter hospital stays, it is less effective than open surgery for severe stenosis, with only 36% achieving normal respiration compared to 76% in the open surgery group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of the CO2 laser in the management of laryngotracheal stenosis: a survey of 100 cases. Monnier, P., George, M., Monod, ML., et al.[2018]

In a study of 127 patients treated for laryngotracheal stenosis, major reconstructive procedures like laryngotracheoplasty (LTP), cricotracheal resection (CTR), and tracheal resection (TR) were found to be well tolerated, with only 28% of patients requiring further therapy after these interventions.

Initial dilation for laryngotracheal stenosis often leads to the need for additional procedures, as 70% of patients who underwent dilation required subsequent interventions, highlighting the effectiveness of major reconstructive surgeries as a primary treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern management of laryngotracheal stenosis. Herrington, HC., Weber, SM., Andersen, PE.[2022]

In a study of 66 patients with benign tracheal stenosis, tracheal stenting (ST) was found to be significantly more effective than balloon dilatation (BA) in maintaining tracheal patency over a 2-year period, especially in patients with complex stenosis.

However, ST was associated with a higher rate of adverse events compared to BA, indicating that while it may offer better efficacy, it also comes with increased risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stenting versus balloon dilatation in patients with tracheal benign stenosis: The STROBE trial. Marchioni, A., Andrisani, D., Tonelli, R., et al.[2022]

A patient experienced respiratory arrest 4 hours after laser treatment for tracheal stenosis, highlighting a potential risk associated with this procedure.

The respiratory arrest was likely caused by airway narrowing due to delayed tissue swelling from thermal injury, indicating the need for careful monitoring after laser interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory arrest after successful neodymium:yttrium-aluminum-garnet laser treatment of subglottic tracheal stenosis. Abdelmalak, B., Ryckman, JV., AlHaddad, S., et al.[2019]

The authors successfully treated tracheal stenosis in two cases caused by prolonged intubation and tracheostomy using a combination of rigid bronchoscopy, laser therapy, and topical mitomycin C, highlighting a potential effective approach for this challenging condition.

Mitomycin C was used as an adjuvant treatment to help prevent scar formation and reestenosis, which are common causes of treatment failure in tracheal stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bronchoscopic dilation techniques and topical application of mitomycin-C in the treatment of tracheal stenosis post intubation - two case reports]. Ferreira, S., Nogueira, C., Oliveira, A., et al.[2019]

A new endoscopic technique using a hand drill was successfully applied to treat simple web-like tracheal stenosis in 5 patients who were unfit for surgery, demonstrating a safe alternative to traditional surgical methods.

The procedure resulted in no intraoperative or postoperative complications, and there was no recurrence of stenosis after an average follow-up of 26 months, indicating its efficacy and safety for managing benign tracheal stenoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new endoscopic hand drill for management of tracheal stenosis. Batzella, S., Lucantoni, G., Fiorelli, A., et al.[2018]

The study of 16 patients with tracheal stenosis showed that bronchoscopic delivery of a carbon dioxide laser is an effective treatment method, with 81.3% of patients successfully decannulated after the procedure.

Most cases of tracheal stenosis were related to intubation, and the average follow-up period was about 24 months, indicating that this laser treatment can provide long-term benefits for patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CO₂ laser treatment of tracheal stenosis. Ozkul, Y., Songu, M., Imre, A., et al.[2016]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Long-term results after 110 tracheal resections. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Fiberoptic-Guided Blue Rhino Dilator-Assisted Dilation of Postintubation Tracheal Stenosis: A Case Report About a Novel Technique. [2017]

3. England pubmed.ncbi.nlm.nih.gov

How we do it: endoscopic tracheal dilatation technique using a supraglottic airway device and non-occlusive balloon. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

The role of the CO2 laser in the management of laryngotracheal stenosis: a survey of 100 cases. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Modern management of laryngotracheal stenosis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Stenting versus balloon dilatation in patients with tracheal benign stenosis: The STROBE trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Respiratory arrest after successful neodymium:yttrium-aluminum-garnet laser treatment of subglottic tracheal stenosis. [2019]

8. Spain pubmed.ncbi.nlm.nih.gov

[Bronchoscopic dilation techniques and topical application of mitomycin-C in the treatment of tracheal stenosis post intubation - two case reports]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A new endoscopic hand drill for management of tracheal stenosis. [2018]

10. England pubmed.ncbi.nlm.nih.gov

CO₂ laser treatment of tracheal stenosis. [2016]