Transcriptomic Profile Changes: CO2 Laser Wedge Resection vs Radial Incision for Benign Tracheal Stenosis
This study aims to compare the changes in transcriptomic pathway activation scores between CO2 laser wedge resection and radial incision treatments for benign tracheal stenosis.
Bronchoscopy, carbon dioxide (CO2) laser wedge resection
+ Radial incision with dilation
Respiratory Tract Diseases
+ Tracheal Diseases
+ Tracheal Stenosis
Treatment Study
Summary
Study start date: May 1, 2026
Actual date on which the first participant was enrolled.Benign tracheal stenosis (BTS) is a rare but serious condition where the airway narrows due to scarring from causes like post-intubation or tracheostomy. The standard treatment involves bronchoscopic procedures, but recurrence rates are high and the best technique is uncertain. This study focuses on two common methods: carbon dioxide (CO₂) laser wedge resection and radial incision with dilation. While there's some evidence that wedge resection may have lower recurrence rates and longer recurrence-free intervals, the reasons behind this aren't fully understood. This research involves a randomized pilot study with 40 BTS patients, comparing the two methods. Before and one month after the procedure, endobronchial biopsies are collected and analyzed using bulk ribonucleic acid (RNA) sequencing and spatial transcriptomics. This dual approach helps map molecular pathways related to fibrosis resolution, immune cell dynamics, and epithelial repair. Patients are monitored for two years with standard clinical, physiologic, and imaging assessments. The molecular findings are then linked with recurrence-free survival and other significant outcomes. The aim is to fill critical knowledge gaps in understanding BTS management, potentially improving treatment selection and identifying new therapeutic targets to prevent recurrence.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location