Dilatation vs. Laser Resection for Tracheal Stenosis

(AERATE Trial)

Not currently recruiting at 3 trial locations

Overseen By Marc Fortin

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Under 18, Pregnant, Inflammatory conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to treat benign tracheal stenosis, a condition where the windpipe narrows and makes breathing difficult. One method, endoscopic laser resection, uses a laser to vaporize the narrowed section of the windpipe. The other method, dilatation, employs a balloon or rigid tool to widen it. The trial aims to determine which method more effectively treats this condition. Individuals with tracheal stenosis less than 1 cm long and without cartilage damage may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance treatment options for future 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both dilatation and endoscopic laser resection are generally safe treatments for tracheal stenosis, a condition where the windpipe narrows. Studies have found that dilatation, which widens the narrowed airway with a balloon or rigid tool, is usually safe, though serious complications like airway tears are rare.

Endoscopic laser resection, which uses a laser to remove narrowed tissue, is also considered safe. One study found major complications in only about 1.2% of procedures, with minor issues in about 6.3% of cases. Overall, patients typically handle the procedure well without major problems.

In summary, both treatments have been safely used in many cases. Serious complications are uncommon, and most patients tolerate both methods well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the trial comparing two techniques for treating tracheal stenosis: dilatation and endoscopic laser resection. Most current treatments involve surgical intervention or stenting to open up the narrowed trachea. Endoscopic laser resection is unique because it uses a CO2 or diode laser to precisely vaporize the constricted tracheal tissue, potentially reducing stenosis to less than 20% without the need for further dilatation. On the other hand, dilatation involves expanding the trachea using a balloon or bronchoscope, which can be enhanced with a radial incision using electrocautery or laser. Both approaches aim to improve airway openness, but the laser resection offers a precise, potentially less invasive method that excites researchers about its effectiveness and safety.

What evidence suggests that this trial's treatments could be effective for tracheal stenosis?

This trial will compare two treatments for benign tracheal stenosis: dilatation and endoscopic laser resection. Research has shown that both widening the windpipe through dilatation and using a laser to remove tissue can effectively treat this condition. Studies indicate that using a balloon to widen the windpipe provides quick relief with less pain and a lower risk of infection. This method safely and often successfully opens the airway. Conversely, using a laser to remove tissue has proven very effective, with many patients experiencing good results and few complications. Some studies suggest that laser treatment might be more effective than balloon widening in certain situations. Both methods have their advantages, and their success can depend on the specific condition of the patient. Participants in this trial will be assigned to one of these treatment arms to evaluate their effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Marc Fortin

Principal Investigator

Fondation IUCPQ

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either endoscopic laser resection or dilatation for tracheal stenosis

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dilatation
• Endoscopic laser resection

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Tracheal dilation for:

• Benign tracheal stenosis
• Subglottic stenosis

Approved in European Union as Endoscopic airway dilation for:

• Tracheal stenosis
• Subglottic stenosis

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4240492/

Long-Term Results of Endoscopic Dilatation for Tracheal ... The purpose of this study was to assess the long-term results of endoscopic dilatation of airway stenosis and to evaluate predictive factors for favorable ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0385814623001426

Endoscopic balloon dilatation in the management of ... Endoscopic balloon dilatation (EBD) has the advantages of reduced invasiveness, a shorter operative time, lower infection risk, less pain and a shorter ...

3. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/treating-benign-subglottic-and-tracheal-stenosis-which-endoscopic-approach-has-better-outcomes

Treating Benign Subglottic and Tracheal Stenosis - Consult QD Balloon and rigid bronchoplasty were shown to be equally effective and safe in the early management of benign SGTS.

4. cts.springeropen.com cts.springeropen.com/articles/10.1186/s43057-021-00052-5

Balloon tracheoplasty for tracheal stenosis after prolonged ... Balloon tracheoplasty is a simple, safe method and could be a promising and effective approach that offers immediate symptomatic relief for tracheal stenosis.

5. jcvaonline.com jcvaonline.com/article/S1053-0770(22)00113-6/fulltext

Prospective Observational Trial of a Nonocclusive ... The study authors here assessed an innovative nonocclusive tracheal dilatation balloon, which may improve patient safety by allowing continuous gas exchange.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7317836/

Balloon dilatation for paediatric airway stenosis To assess the safety and efficacy in routine clinical practice of balloon dilatation procedures in the treatment of paediatric airway stenosis.

7. tandfonline.com tandfonline.com/doi/full/10.1080/23772484.2023.2244672

Successful treatment of a level IIIA tracheal rupture ... Endoscopic balloon dilation of tracheal stenosis is usually a safe procedure. However, there are life-threatening complications that ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1053077022001136

Prospective Observational Trial of a Nonocclusive ... The study authors here assessed an innovative nonocclusive tracheal dilatation balloon, which may improve patient safety by allowing continuous gas exchange.

9. smw.ch smw.ch/index.php/smw/article/view/3363/5950

Endoscopic treatment of benign tracheal stenosis In this retrospective single-centre study, we aimed to evaluate the safety and outcome of endoscopic tracheoplasty in patients with benign tracheal stenosis, ...

10. bostonscientific.com bostonscientific.com/en-US/medical-specialties/pulmonology/treatment-of-tracheal-stenosis-with-cre--pulmonary-balloon-dilat.html

Treatment of Tracheal Stenosis with CRE™ Pulmonary ... Outcome of Procedure. Prior to serial balloon dilation, the patient had 90% airway obstruction. Following serial balloon dilation, the patientachieved normal ...