Transcriptomic Profile Changes in Benign Tracheal Stenosis: Wedge Resection vs. Radial Incision

Official title

A Randomized Controlled Trial Comparing Transcriptomic Profile Changes Following Carbon Dioxide (CO2) Laser Wedge Resection Versus Radial Incision for Benign Tracheal Stenosis

Overview

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.

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.

Interventions

• Procedure Bronchoscopy, carbon dioxide (CO2) laser wedge resection
  CO2 laser wedge resection - removing scar tissue with laser, leading tissue bridges.
• Procedure Radial incision with dilation
  Radial incision with dilation - making radial cuts at the circumferential scar site, followed by balloon dilation.

Primary outcome measures

• Change in transcriptomic pathway activation scores [Time frame: at the time of the second procedure (1 month from the initial invervention)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Maryland — Baltimore

Publications

• Kang N, Ho A, Bain PA, Zhang C. Comparing CO2 Laser Wedge Resection to Radial Incision With Dilation in the Endoscopic Treatment of Benign Tracheal Stenosis: A Systematic Review. J Bronchology Interv Pulmonol. 2026 Feb 20;33(2):e01064. doi: 10.1097/LBR.0000000000001064. eCollection 2026 Apr 1. PMID 41718210

Identifiers

NCT: NCT07463742 · HP-00112650

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗