Observational, Prospective, Multicenter Study on the Diagnostic Accuracy, Safety and Tolerability, Predictors of Success of EUS-B-FNA in the Diagnosis of Malignant Parenchymal Lung Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 4
- 主要终点
- Sensitivity and specificity of EUS-B-FNA in the detection of malignant pulmonary lesions
研究概览
简要总结
The aim of this study is to evaluate the diagnostic accuracy, safety and tolerability, predictors of success of EUS-B-FNA in the diagnosis of malignant parenchymal lung lesions.
The Investigators will also evaluated the adequacy of samples obtained for molecular analysis in patients with Non-Small Cell Lung Cancer (NSCLC)
详细描述
Lung cancer is by far the leading cause of cancer death among both men and women worldwide. Non-Small Cell Lung Cancer (NSCLC) represents about 80-90% of all lung cancers. Endoscopic ultrasound with bronchoscope fine needle aspiration (EUS-B-FNA) is a safe and accurate technique that has been mostly described for the diagnosis and the mediastinal nodal staging of NSCLC, as a complementary technique to endobronchial ultrasound trans-bronchial needle aspiration (EBUS-TBNA) or when EBUS-TBNA may be difficult and/or contraindicated for clinical reasons (e.g. excessive cough, respiratory failure etc).
Few retrospective studies evaluated the sensitivity and the safety of this technique in the diagnosis of parenchymal pulmonary lesions suspected for lung cancer, in contact or adjacent to the esophagus. Few data are available on the adequacy of the samples obtained by EUS-B-FNA for molecular analysis in NSCLC. The main predictors of success are still unclear.
The primary aim of this prospective study is to evaluate the diagnostic accuracy of EUS-B-FNA in the diagnosis of malignant parenchymal lung lesions. The Investigators will also evaluate the safety and tolerability of the technique, the main predictors of success and the adequacy of samples obtained for molecular analysis in patients with NSCLC
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Adult patients with a lung parenchymal lesion suspected for malignancy, in contact or adjacent to the esophagus at the CT scan (with or without mediastinal lymph adenopathies), requiring a pathological diagnosis:
- •which can not be sample by bronchoscopy/EBUS-TBNA or
- •with a previous not diagnostic bronchoscopy/EBUS-TBNA or
- •with clinical/anesthesiological contraindications to bronchoscopy/EBUS-TBNA or
- •with a previous nodal EUS-B-FNA not diagnostic/not adequate at the ROSE
- •Patients with lung parenchymal lesions who are able to sign the informed consent for the study participation
排除标准
- •Patients with lung parenchymal lesions of known etiology;
- •Patients with lung parenchymal lesions in whom bronchoscopic ultrasound-guided trans- esophageal needle aspiration is contraindicated;
- •Patients with lung parenchymal lesions who refuse/are not able to sign the informed consent for the study participation
结局指标
主要结局
Sensitivity and specificity of EUS-B-FNA in the detection of malignant pulmonary lesions
时间窗: At study completion (expected February 2021)
Diagnostic accuracy (i.e., sensitivity and specificity) of EUS-B-FNA in the diagnosis of malignant pulmonary parenchymal lesions, discriminating those with a malignant disease in comparison with those without the malignant disease. A specific unit of measure is not included, being the computation of the present outcome based on the absolute number of malignant/non malignant cases to the total number of diagnosed individuals.
次要结局
- Absolute and relative frequency of adequate samples for molecular analysis in NSCLC following assessment by pathologist/molecular biologist(At study completion (expected February 2021))
- Detection of predictors of successful aspirate based on the implementation of regression models(At study completion (expected February 2021))
- Safety (number of adverse events) of EUS-B-FNA through CTCAE v4.0(Until 24 hours after the procedure)
研究者
Michele Mondoni
MD, Principal Investigator
University of Milan