40 Participants NeededMy employer runs this trial

Wedge Resection vs Radial Incision for Tracheal Stenosis

CZ
Overseen ByChenchen Zhang, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Maryland, Baltimore
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how airway tissue changes and heals after common treatments for benign tracheal stenosis, a condition where the windpipe narrows and makes breathing difficult. Researchers will study two procedures: radial incision and dilation, and carbon dioxide laser wedge resection. They will analyze small tissue samples collected during these procedures to learn more about airway healing. This trial suits individuals with tracheal stenosis symptoms due to intubation, a benign cause, or an unknown reason. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatment options for tracheal stenosis.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that two methods, CO2 laser wedge resection and radial incision with dilation, have been studied for their safety in treating tracheal stenosis, a narrowing of the windpipe.

For CO2 laser wedge resection, studies indicate a low risk of complications. Out of 212 patients, about 3% experienced major issues, and 17% had minor ones. This means that for every 100 procedures, around 3 might have a major problem, and 17 might have minor ones. The procedure is generally considered effective and safe for certain cases of tracheal stenosis.

Radial incision and dilation have also been found to be safe. Research shows that this method, often performed without a hospital stay, is routinely conducted safely. In one study, 38 patients had no complications after the procedure, suggesting it is a reliable way to treat tracheal narrowing.

Both treatments are generally well-tolerated, with some risk of minor complications. These findings are important for anyone considering participating in a clinical trial involving these procedures.12345

Why are researchers excited about this trial?

Researchers are excited about the trial comparing wedge resection and radial incision for tracheal stenosis because each technique offers distinct advantages over traditional treatments like balloon dilation and stenting. The CO2 laser wedge resection aims to precisely remove scar tissue with minimal damage to surrounding areas, potentially leading to fewer complications and quicker recovery. On the other hand, radial incision and dilation could offer a less invasive option that maintains airway integrity while expanding the narrowed section. This trial seeks to uncover which method could provide longer-lasting relief and better outcomes for patients suffering from this challenging condition.

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

This trial will compare two treatments for tracheal stenosis: carbon dioxide (CO2) laser wedge resection and radial incision with dilation. Research has shown that using a CO2 laser to treat benign tracheal stenosis is effective. Specifically, studies found a lower recurrence rate of 43.2% with CO2 laser treatment, compared to 66.1% for radial incision with dilation. This suggests that CO2 laser treatment might offer longer-lasting relief. Additionally, 81.3% of patients treated with the CO2 laser were able to breathe without needing a tube in their throat. These findings indicate that CO2 laser treatment could be a promising option for treating tracheal stenosis.13678

Are You a Good Fit for This Trial?

This trial is for people who have trouble breathing due to a non-cancerous narrowing of the windpipe, either from unknown causes or after medical procedures like intubation. It does not include those with autoimmune diseases, infections like TB, tumors, cartilage damage, or other airway problems.

Inclusion Criteria

Symptomatic tracheal stenosis
Idiopathic subglottic stenosis
Iatrogenic tracheal stenosis from intubation or tracheostomy

Exclusion Criteria

Positive ANA or ANCA
Tracheal stenosis from infection, i.e. TB
Tracheal stenosis with cartilage fracture
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either CO2 laser wedge resection or radial incision with dilation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with endobronchial biopsies collected before and one month after intervention

2 years
Standardized clinical, physiologic, and imaging assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Radial Incision
  • Wedge Resection

Trial Overview

The study compares two standard treatments for tracheal narrowing: CO2 laser wedge resection and radial incision with dilation using a bronchoscope. Tissue samples are collected before and after treatment to study how the airway heals.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Carbon dioxide (CO2) laser wedge resectionExperimental Treatment1 Intervention
Group II: Radial incision and dilationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

Citations

Comparing CO2 Laser Wedge Resection to Radial Incision ...

CO2 laser wedge resection was associated with a lower recurrence rate (43.2%) compared with those treated with radial incision with dilation ( ...

Comparing CO2 Laser Wedge Resection to Radial Incision ...

CO2 laser wedge resection was associated with a lower recurrence rate (43.2%) compared with those treated with radial incision with dilation (66.1%), ...

Comparing CO2 Laser Wedge Resection to Radial Incision ...

CO2 laser wedge resection may be superior to radial incision with dilation in reducing recurrence of BTS, particularly over long-term ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32820819/

Endoscopic Wedge Excisions with CO2 Laser for ...

Endoscopic Wedge Excisions with CO2 Laser for Subglottic Stenosis. Laryngoscope. 2021 Apr;131(4):E1062-E1066. doi: 10.1002/lary.29013. Epub 2020 Aug 21.

CO2 laser treatment of tracheal stenosis - Prof. Dr. Murat Songu

Postoperative decannulation was achieved in 13 patients (81.3%), and decannulation was not achieved in three patients (18.7%). Keywords: ...

Complications following laser wedge excision for idiopathic ...

Amongst 212 iSGS patients who underwent 573 LWE procedures there was 3.3 % major complication rate (1.2 % per procedure) and a 17 % minor complication rate (6.3 ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32877381/

The CO2-laser in the treatment of laryngeal and tracheal ...

The aim of this study was to evaluate the results that may be obtained in the treatment of laryngotracheal stenosis by endoscopy using the CO2 laser.

Tracheal wedge excision for pediatric idiopathic ...

Surgical treatment involves carbon dioxide laser scar excisions as an alternative to traditional endoscopic balloon dilation that may propagate ...