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

NCT07086729 | Not Yet Recruiting

• 1 other identifier: B.30.2.ODM.0.20.08/ 457
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tracheal Stenosis

Keywords

Tracheal Stenosis; Postintubation Stenosis; Hounsfield Unit; Morphologic Scoring; Computed Tomography

Outcome Measures

Primary Outcomes (3)

• 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

  From initial diagnosis to surgical decision (up to 12 months)

• 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

  From initial diagnosis to surgical decision (up to 12 months)

• 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)

  From initial diagnosis to surgical decision (up to 12 months)

Study Arms (1)

Tracheal Stenosis Patients

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.

Other: CT-Based Morphologic and Attenuation Scoring

Interventions

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.

Tracheal Stenosis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

MeSH Terms

Conditions

Tracheal Stenosis

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases

Central Study Contacts

Caner İşevi, MD

CONTACT

+903623121919; drcanerisevi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 25, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 30, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share