Diagnostic Accuracy of Endobronchial Ultrasound Needle Aspiration With and Without Suction: a Single-center Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mediastinal Lymphadenopathy
- Sponsor
- Università Politecnica delle Marche
- Enrollment
- 306
- Locations
- 1
- Primary Endpoint
- To compare the diagnostic yield of active suction vs passive suction vs no suction EBUS-TBNA in the diagnosis of hilar/mediastinal adenopathies
- Last Updated
- 3 years ago
Overview
Brief Summary
The main purpose of the present study is to compare the diagnostic yield of different aspiration techniques in Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) in the diagnosis of hilar/mediastinal adenopathy
Detailed Description
The role of ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for the diagnosis of hilar/mediastinal adenopathy is well established. However, different aspiration techniques are available and it's not clear if there's a significant difference between suction vs no suction aspiration. Of great interest is the role of different aspiration techniques in EBUS-TBNA in determining the diagnostic yield for histopathological evaluation, including molecular biology and PD-L1 amplification assessment in lung cancer diagnosis. In this context, no comparative studies between suction and no suction aspiration have been performed; moreover, considering only suction techniques, no studies evaluated if there's a difference between aspiration with EBUS dedicated syringe and manual aspiration through Cameco syringe. It is very important for clinical practice to definitively assess the non inferiority of no suction techniques in EBUS-TBNA in terms of diagnostic yield, and to provide information regarding the quality of histologic sample to define the best diagnostic strategy. The study is focused on a minimum of 306 patients who have at least one hilar/mediastinal lymph node \> 1 cm on CT scan or hypermetabolic on FDG-PET in at least one approachable lymph nodal station for which a diagnostic cyto-histological assessment is required for clinical purpose. Patients will be randomized 1:1:1 (no suction : passive suction with EBUS dedicated syringe : manual suction with Cameco syringe) by a computer-generated random-allocation system to undergo EBUS-TBNA with one of the three different aspiration techniques. The pathologist provides a final diagnosis and, as secondary endpoint, a qualitative assessment of the sample quality using both a binary and a semi-quantitative score.
Investigators
Stefano Gasparini
Professor
Università Politecnica delle Marche
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 and/or hypermetabolic adenopathy assessed by FDG-PET;
- •ability to give an informed consent
Exclusion Criteria
- •coagulopathy or bleeding diathesis that cannot be corrected;
- •severe refractory hypoxemia;
- •unstable hemodynamic status;
- •inability to give an informed consent
Outcomes
Primary Outcomes
To compare the diagnostic yield of active suction vs passive suction vs no suction EBUS-TBNA in the diagnosis of hilar/mediastinal adenopathies
Time Frame: 36 months
The diagnostic yield is defined as the rate of diagnoses/total of cases. Assuming that the best technique provides a diagnostic yield of 94%, the non inferiority is defined if the difference between the best and the worst method is less than 3% with a non-inferiority limit of 10%.
Secondary Outcomes
- Adeguacy for molecular assessment in lung cancer(36 months)
- Qualitative evaluation of the sample by the pathologist(36 months)