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

NCT ID: NCT07086729

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-01-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

CT-Based Morphologic and Attenuation Scoring

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Caner İşevi, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Caner İşevi, MD

Role: CONTACT

drcanerisevi@gmail.com

+903623121919 ext. 4240

Other Identifiers

B.30.2.ODM.0.20.08/ 457

Identifier Type: -

Identifier Source: org_study_id