CT-Based Scoring System to Predict Surgical Need in Tracheal Stenosis (TSMAS Study)
ConditionTracheal Stenosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOndokuz Mayıs University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of adult patients (aged 18 and older) diagnosed with tracheal stenosis, who underwent thoracic CT imaging at the time of diagnosis. All patients were treated or followed at Ondokuz Mayıs University Hospital between 2000 and 2025. Only patients with sufficient-quality DICOM-format CT scans and no prior tracheal surgery or radiotherapy were included.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
CT-Based Morphologic and Attenuation Scoring
Other interventionRetrospective 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Tracheal Stenosis Patients1 intervention
Trial outcomes
Primary outcomes
1
Prediction of Surgical Requirement Based on Tracheal Diameter on Initial CT
Evaluation of whether smaller tracheal diameter on initial CT is associated with need for surgery. Unit of Measure: millimeters
Time frame
From initial diagnosis to surgical decision (up to 12 months)2
Prediction of Surgical Requirement Based on Tracheal Wall Thickness on Initial CT
Evaluation of whether increased tracheal wall thickness on initial CT predicts surgical need. Unit of Measure: millimeters
Time frame
From initial diagnosis to surgical decision (up to 12 months)3
Prediction of Surgical Requirement Based on HU Values of the Stenotic Segment on CT
Evaluation of whether high HU values in the stenotic segment predict surgical need. Unit of Measure: Hounsfield Units (HU)
Time frame
From initial diagnosis to surgical decision (up to 12 months)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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