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

NCT07463742 | Not Yet Recruiting DMC

• 1 other identifier: HP-00112650
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tracheal Stenosis

Keywords

tracheal stenosis; bronchoscopy; wedge resection; CO2 laser

Outcome Measures

Primary Outcomes (1)

• Change in transcriptomic pathway activation scores

  at the time of the second procedure (1 month from the initial invervention)

Study Arms (2)

Carbon dioxide (CO2) laser wedge resection

EXPERIMENTAL

Procedure: Bronchoscopy, carbon dioxide (CO2) laser wedge resection

Radial incision and dilation

ACTIVE COMPARATOR

Procedure: Radial incision with dilation

Interventions

Bronchoscopy, carbon dioxide (CO2) laser wedge resection PROCEDURE

CO2 laser wedge resection - removing scar tissue with laser, leading tissue bridges.

Carbon dioxide (CO2) laser wedge resection

Radial incision with dilation PROCEDURE

Radial incision with dilation - making radial cuts at the circumferential scar site, followed by balloon dilation.

Radial incision and dilation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic tracheal stenosis
• idiopathic subglottic stenosis
• iatrogenic tracheal stenosis from intubation or tracheostomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21021, United States

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Tracheal Stenosis

Interventions

Bronchoscopy; Carbon Dioxide; Dilatation

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds; Investigative Techniques

Central Study Contacts

Chenchen Zhang, MD

CONTACT

410-328-8138; chenchen.zhang@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1\. Carbon dioxide (CO2) laser wedge resection; 2. Radial incision and dilation

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2032
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 5/1/2026 to 5/1/2036
• 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.

Locations

US (1)