CT-Based Scoring System to Predict Surgical Need in Tracheal Stenosis (TSMAS Study)

This study aims to develop a CT-based scoring system to help predict whether patients with tracheal stenosis will require surgical treatment or can be managed with endoscopic procedures. Using retrospective data, researchers will evaluate CT scans of patients diagnosed with tracheal stenosis to measure features such as airway diameter, wall thickness, and tissue density (measured in Hounsfield Units). The goal is to create a non-invasive, reproducible, and objective tool-called the Tracheal Stenosis Morphology and Attenuation Score (TSMAS)-that can support clinical decision-making and improve treatment planning.

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Key information

Conditions

Tracheal Stenosis Respiratory Tract Diseases Tracheal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years
Diagnosed with tracheal stenosis
Underwent thoracic CT imaging at the time of diagnosis
CT scans available in adequate quality and in DICOM format
No prior surgical treatment for tracheal stenosis before CT imaging

Exclusion criteria

Tracheal stenosis due to malignancy, foreign body, or tracheobronchial tumors
History of tracheal surgery before CT imaging
Poor quality CT images (e.g., motion artifacts, incomplete tracheal segments)
Patients with a history of radiotherapy (RT) to the neck or mediastinum

Treatment and study plan

CT-Based Morphologic and Attenuation Scoring

Other

Retrospective analysis of CT images to extract morphological and Hounsfield Unit (HU) parameters for development of a predictive scoring model (TSMAS). No clinical or therapeutic intervention was performed.

Primary outcomes

Prediction of Surgical Requirement Based on Tracheal Diameter on Initial CT

Time frame: From initial diagnosis to surgical decision (up to 12 months)

Evaluation of whether smaller tracheal diameter on initial CT is associated with need for surgery.

Unit of Measure: millimeters
Prediction of Surgical Requirement Based on Tracheal Wall Thickness on Initial CT

Time frame: From initial diagnosis to surgical decision (up to 12 months)

Evaluation of whether increased tracheal wall thickness on initial CT predicts surgical need.

Unit of Measure: millimeters
Prediction of Surgical Requirement Based on HU Values of the Stenotic Segment on CT

Time frame: From initial diagnosis to surgical decision (up to 12 months)

Evaluation of whether high HU values in the stenotic segment predict surgical need.

Unit of Measure: Hounsfield Units (HU)

Study contacts

Contact information is provided by the study sponsor or research team.

Caner İşevi, MD

CONTACT

[email protected]

+903623121919 ext. 4240

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Development of a CT-Derived Risk Score to Guide Treatment Decision: Tracheal Stenosis Morphology and Attenuation Score (TSMAS)

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jul 25, 2025
Registry last updated: Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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