Clinical trial NCT03983005: EUS-B-FNA in the Diagnosis of Malignant Parenchymal Lung Lesions
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung cancer
Endoscopic ultrasound
EUS-B-FNA
Molecular analysis
Rapid on-site evaluation
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a parenchymal lung lesion suspected for malignancy in contact or adjacent to the esophagus at the CT scan, who need a pathological diagnosis.

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

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

Primary outcomes:
measure: Sensitivity and specificity of EUS-B-FNA in the detection of malignant pulmonary lesions
timeFrame: At study completion (expected February 2021)
Secondary outcomes:
measure: Absolute and relative frequency of adequate samples for molecular analysis in NSCLC following assessment by pathologist/molecular biologist
timeFrame: At study completion (expected February 2021)
measure: Detection of predictors of successful aspirate based on the implementation of regression models
timeFrame: At study completion (expected February 2021)
measure: Safety (number of adverse events) of EUS-B-FNA through CTCAE v4.0
timeFrame: Until 24 hours after the procedure
Other outcomes:
Locations:
city: Mestre
country: Italy
facility: UO Pneumologia dell'Ospedale dell'Angelo
state: Venice
city: Ancona
country: Italy
facility: Pulmonology Unit, AOU "Ospedali Riuniti"; Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche
city: Milan
country: Italy
facility: Respiratory Unit, ASST Santi Paolo e Carlo, San Paolo Hospital, Department of Health Sciences, Università degli Studi di Milano
city: Rome
country: Italy
facility: Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore
Study officials:
affiliation: Respiratory Unit, ASST Santi Paolo e Carlo, San Paolo Hospital
name: Michele Mondoni, MD
role: PRINCIPAL_INVESTIGATOR
References: