Transcriptomic Profile Changes in Benign Tracheal Stenosis: Wedge Resection vs. Radial Incision
Purpose
Some people develop a narrowing of their windpipe (trachea), called benign tracheal stenosis, which can make it hard to breathe. Doctors often treat this by using a bronchoscope-a thin, flexible tube with a camera-to open up the airway or remove scar tissue. While these procedures help patients breathe better, we do not fully understand why the narrowing occurs or how the tissue heals afterward. The purpose of this study is to better understand the biological changes in the airway tissue before and after these standard medical procedures. During the procedure, small samples of tissue that would already be collected as part of normal care will be analyzed in the laboratory. The results may help doctors learn more about airway healing and could guide better treatments in the future.
Condition
- Tracheal Stenosis
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 - tracheal stenosis with malacia - tracheal stenosis from malignancy - tracheal stenosis from benign tumor - presence of glottic or supraglottic stenosis
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 1. Carbon dioxide (CO2) laser wedge resection; 2. Radial incision and dilation
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Carbon dioxide (CO2) laser wedge resection |
|
|
|
Active Comparator Radial incision and dilation |
|
Recruiting Locations
Baltimore, Maryland 21021
More Details
- Status
- Recruiting
- Sponsor
- University of Maryland, Baltimore
Detailed Description
Benign tracheal stenosis (BTS) is an uncommon but potentially life-threatening condition caused by fibroinflammatory scarring that narrows the airway. Etiologies include post-intubation, tracheostomy, and idiopathic disease. Bronchoscopic intervention is the first-line treatment; however, recurrence rates exceed 50%, and the optimal technique remains uncertain. Two widely used modalities-carbon dioxide (CO₂) laser wedge resection and radial incision with dilation-have never been directly compared in a randomized trial. Preliminary evidence, including our meta-analysis, suggests wedge resection may yield lower recurrence rates and longer recurrence-free intervals, but the biological mechanisms underlying these differences remain unknown. This project will conduct a randomized pilot study of 40 BTS patients comparing CO₂ laser wedge resection and radial incision with dilation. Endobronchial biopsies will be collected before and one month after intervention and analyzed using bulk ribonucleic acid (RNA) sequencing and spatial transcriptomics to capture both global and spatially resolved gene expression changes. This dual-modality approach will map molecular pathways involved in fibrosis resolution, immune cell dynamics, and epithelial repair. Patients will be followed for two years with standardized clinical, physiologic, and imaging assessments, and molecular signatures will be correlated with recurrence-free survival and other clinically meaningful outcomes. By combining prospective clinical data with high-resolution transcriptomic profiling, this study addresses critical gaps in mechanistic understanding and comparative effectiveness evidence for BTS management. The findings will establish a biologic framework for selecting optimal bronchoscopic approaches, identify candidate therapeutic targets to prevent recurrence, and generate effect-size estimates to power a future multicenter randomized controlled trial.