EUS-B-FNA in the Diagnosis of Malignant Parenchymal Lung Lesions

University of Milan

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: EUS-B-FNA

Study type: Observational

Funder types: Other

Identifiers

NCT03983005

EUS-B

Details and patient eligibility

About

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)

Full description

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

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

107 participants in 1 patient group

Patients with suspected lung cancer

Description:

Patients with pulmonary parenchymal lesions suspected for malignancy in contact or adjacent to the esophagus which can be sampled by EUS-B-FNA

Treatment:

Procedure: EUS-B-FNA