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

NCT ID: NCT03983005

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 107 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2021-05-31

Brief Summary

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)

Detailed 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

Conditions

Lung Cancer

Study Design

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

Study Groups

Patients with suspected lung cancer

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

EUS-B-FNA

Intervention Type: PROCEDURE

Endoscopic ultrasound with bronchoscope fine needle aspiration (EUS-B-FNA) is an endoscopic technique based on a trans-esophageal needle aspiration performed by an interventional pulmonologist with the echo-bronchoscope

Interventions

EUS-B-FNA

Endoscopic ultrasound with bronchoscope fine needle aspiration (EUS-B-FNA) is an endoscopic technique based on a trans-esophageal needle aspiration performed by an interventional pulmonologist with the echo-bronchoscope

Intervention Type: PROCEDURE

Other Intervention Names

Endoscopic ultrasound with bronchoscope fine needle aspiration

Eligibility Criteria

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

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

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Michele Mondoni

MD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Mondoni, MD

Role: PRINCIPAL_INVESTIGATOR

Respiratory Unit, ASST Santi Paolo e Carlo, San Paolo Hospital

Locations

UO Pneumologia dell'Ospedale dell'Angelo

Mestre, Venice, Italy

Pulmonology Unit, AOU "Ospedali Riuniti"; Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche

Ancona, , Italy

Respiratory Unit, ASST Santi Paolo e Carlo, San Paolo Hospital, Department of Health Sciences, Università degli Studi di Milano

Milan, , Italy

Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore

Rome, , Italy

Countries

Italy

Other Identifiers

EUS-B

Identifier Type: -

Identifier Source: org_study_id