Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymphadenopathies
Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Lymphoma
About this trial
This is an interventional diagnostic trial for Mediastinal Lymphadenopathy focused on measuring transbronchial needle aspiration, ultrasound guided transbronchial needle aspiration, sensitivity, hilar/mediastinal adenopathy
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18years;
- presence of at least one hilar/mediastinal adenopathy >1 cm on short axis assessed by contrast-enhanced CT scan in at least one approachable stations other than 2R and 2L;
- ability to give an informed consent.
Exclusion Criteria:
- presence of mediastinal adenopathy in stations 2R and 2L;
- coagulopathy or bleeding diathesis that cannot be corrected;
- severe refractory hypoxemia;
- unstable hemodynamic status;
- inability to give an informed consent.
Sites / Locations
- Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti'
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Conventional TBNA + ROSE
EBUS-TBNA + ROSE
Patients allocated in this group will undergo conventional TBNA, performed in a bronchoscopy suite by the same operator under conscious sedation, using 19-G needle size. Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist. In case of samples obtained from conventional TBNA defined as "non diagnostic", the operator will shift to the EBUS procedure.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs
Patients allocated in the intervention group will undergo EBUS-TBNA procedure, performed in a bronchoscopy suite by the same operator under conscious sedation Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs