跳至主要内容
临床试验/NCT07086729
NCT07086729尚未招募不适用

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

Ondokuz Mayıs University0 个研究点目标入组 80 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
主要终点
Prediction of Surgical Requirement Based on Tracheal Diameter on Initial CT

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Prediction of Surgical Requirement Based on Tracheal Diameter on Initial CT

时间窗: 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 HU Values of the Stenotic Segment on CT

时间窗: 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)

Prediction of Surgical Requirement Based on Tracheal Wall Thickness on Initial CT

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Caner İşevi, MD

Principal Investigator

Ondokuz Mayıs University

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