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Not yet recruiting NCT07086729

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

— Observational Tracheal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CT-Based Morphologic and Attenuation Scoring.
Who it may be relevant to
Registry conditions: Tracheal Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other CT-Based Morphologic and Attenuation Scoring
    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 outcome measures

  • Prediction of Surgical Requirement Based on Tracheal Diameter on Initial CT [Time frame: From initial diagnosis to surgical decision (up to 12 months)]
  • Prediction of Surgical Requirement Based on Tracheal Wall Thickness on Initial CT [Time frame: From initial diagnosis to surgical decision (up to 12 months)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07086729 · B.30.2.ODM.0.20.08/ 457

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗