Endobronchial Ultrasound Needle Aspiration With and Without Suction

Università Politecnica delle Marche

Status: Not yet enrolling

Conditions: PDL1 Gene Mutation; Lung Neoplasms; Hilar Lymphadenopathy; Sarcoidosis; Mediastinal Lymphadenopathy; Tuberculosis; ALK Translocation; Lymphoma; ROS1 Gene Mutation; EGF-R Positive Non-Small Cell Lung Cancer

Treatments: Procedure: Passive suction through dedicated EBUS-TBNA syringe; Procedure: No suction EBUS-TBNA; Procedure: Manual applied suction EBUS-TBNA through a pistol-grip syringe holder

Study type: Interventional

Funder types: Other

Identifiers

NCT05110950

AspiraTE2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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306 participants in 3 patient groups

No suction EBUS-TBNA

Active Comparator group

Description:

In this technique the stylet is slowly removed without any kind of device in order to avoid active suction.

Treatment:

Procedure: No suction EBUS-TBNA

Passive suction through dedicated EBUS-TBNA syringe

Active Comparator group

Description:

After rapid stylet removal, suction is applied through a vacuteiner syringe, without active aspiration.

Treatment:

Procedure: Passive suction through dedicated EBUS-TBNA syringe

Manual applied suction EBUS-TBNA through a pistol-grip syringe holder

Active Comparator group

Description:

After rapid stylet removal, suction is applied through Cameco syringe pistol, that can apply active suction manually.

Treatment:

Procedure: Manual applied suction EBUS-TBNA through a pistol-grip syringe holder