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

NCT07086729 — Completed, 69 participants, Ondokuz Mayıs University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07086729
Status	Completed
Study type	Observational
Enrollment	69 (Actual)
Sponsor	Ondokuz Mayıs University (Other)
Conditions	Tracheal Stenosis
Interventions	CT-Based Morphologic and Attenuation Scoring (Other)
Dates	start 2025-09-01, primary completion 2025-12-01, completion 2026-01-30, first posted 2025-07-25, last updated 2026-10-20
Locations	1 site in Turkey (Türkiye)

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Tracheal Stenosis Patients		Other: CT-Based Morphologic and Attenuation Scoring	Patients diagnosed with tracheal stenosis whose thoracic CT scans were retrospectively analyzed to evaluate morphological and densitometric parameters. No intervention was applied; data were used to develop a CT-based risk score (TSMAS) to predict the need for surgical treatment.

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.

+Outcome measures

Primary outcomes

Prediction of Surgical Requirement Based on Tracheal Diameter on Initial CT [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 [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 [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)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Ondokuz Mayıs University, Faculty of Medicine	Samsun	Turkey (Türkiye)