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

March 12, 2026 updated by: Chenchen Zhang, University of Maryland, Baltimore

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radial incision and dilation
Procedure: Radial incision with dilation
Radial incision with dilation - making radial cuts at the circumferential scar site, followed by balloon dilation.
Experimental: Carbon dioxide (CO2) laser wedge resection
Procedure: Bronchoscopy, carbon dioxide (CO2) laser wedge resection
CO2 laser wedge resection - removing scar tissue with laser, leading tissue bridges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in transcriptomic pathway activation scores
Time Frame: at the time of the second procedure (1 month from the initial invervention)
at the time of the second procedure (1 month from the initial invervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

May 1, 2032

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00112650

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) from this study will be shared in a de-identified form for research purposes only, consistent with participant confidentiality protections. The shared dataset will include:

Clinical data: age, sex, relevant medical history related to benign tracheal stenosis, treatment type (CO₂ laser wedge resection vs. radial incision with dilation), recurrence status, symptom scores, spirometry results (PIF, PEF), and imaging findings.

Transcriptomic data: bulk RNA-seq and spatial RNA-seq gene expression data from pre- and post-treatment tissue samples, without any personally identifiable information.

Exclusions:

No names, initials, dates of birth, social security numbers, or other direct identifiers will be shared. All samples and data will be linked only by unique study codes.

Intended Use:

Shared data will be available to qualified researchers for secondary analyses of benign tracheal stenosis or related molecular research, in accordance with institutional an

IPD Sharing Time Frame

5/1/2026 to 5/1/2036

IPD Sharing Access Criteria

Who can access: Only qualified researchers who have submitted a request and agreed to the terms of use, including confidentiality and data security requirements, will have access to the shared IPD. These researchers must be affiliated with an academic, clinical, or research institution.

What they can access: De-identified datasets including clinical data (age, sex, medical history, treatment type, recurrence status, symptom scores, spirometry, imaging) and transcriptomic data (bulk RNA-seq and spatial RNA-seq). No personally identifiable information (names, initials, dates of birth, social security numbers) will be included.

How they can access: Access will be provided through a secure, password-protected database or data repository approved by the institution. Researchers must complete a data use agreement specifying that data are for research purposes only and will not be shared further.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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