Endobronchial Ultrasound Needle Aspiration With and Without Suction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-06-26

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Both the pathologist and the patient are not aware of the type of adopted aspiration technique

Study Groups

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No suction EBUS-TBNA

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

Group Type ACTIVE_COMPARATOR

No suction EBUS-TBNA

Intervention Type PROCEDURE

The needle is moved from a side to side of the lymphnode for 15 times. Each lymphnode is sampled three times.

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.

Passive suction through dedicated EBUS-TBNA syringe

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

Group Type ACTIVE_COMPARATOR

Passive suction through dedicated EBUS-TBNA syringe

Intervention Type PROCEDURE

The needle is moved from a side to side of the lymphnode for 15 times. Each lymphnode is sampled three times.

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.

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

The needle is moved from a side to side of the lymphnode for 15 times. Each lymphnode is sampled three times.

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..

Interventions

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No suction EBUS-TBNA

The needle is moved from a side to side of the lymphnode for 15 times. Each lymphnode is sampled three times.

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.

Intervention Type PROCEDURE

Passive suction through dedicated EBUS-TBNA syringe

The needle is moved from a side to side of the lymphnode for 15 times. Each lymphnode is sampled three times.

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.

Intervention Type PROCEDURE

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

The needle is moved from a side to side of the lymphnode for 15 times. Each lymphnode is sampled three times.

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..

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No