跳至主要内容
临床试验/NCT02009319
NCT02009319已完成不适用

Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients

The University Clinic of Pulmonary and Allergic Diseases Golnik1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
elastography strain ratio

研究概览

简要总结

The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue diagnosis as a gold standard.

详细描述

Evaluation will be performed on consenting consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan. Eligible patients should have either enlarged discrete N2/N3 lymph nodes, or central tumor or enlarged N1 lymph nodes with normal mediastinal lymph nodes. Exclusion criteria will be metastatic disease, severe co-morbidity that disqualified surgical treatment, mediastinal infiltration by tumor and small peripheral lung tumor with normal-sized mediastinal lymph nodes.

Outcomes: Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) for probability of malignant lymph node diagnosis, determined by elastography strain ratio. Receiver operating characteristic (ROC) analysis will be made to display specificity / sensitivity for different strain ratio cut-off values. Area under the ROC curve will be calculated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • enlarged discrete N2/N3 lymph nodes
  • central tumor with normal mediastinal lymph nodes
  • enlarged N1 lymph nodes with normal mediastinal lymph nodes

排除标准

  • metastatic disease
  • severe co-morbidity that disqualified surgical treatment
  • mediastinal infiltration by tumor
  • small peripheral lung tumor with normal-sized mediastinal lymph nodes

结局指标

主要结局

elastography strain ratio

时间窗: up to 7 months

Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV)

次要结局

未报告次要终点

研究者

发起方
The University Clinic of Pulmonary and Allergic Diseases Golnik
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleš Rozman

MD, specialist from pulmonary diseases

The University Clinic of Pulmonary and Allergic Diseases Golnik

研究点 (1)

Loading locations...

相似试验

Endobronchial Ultrasound Elastography: the Utility... | 临床试验