Endobronchial Ultrasound Needle Aspiration With and Without Suction

Diagnostic Accuracy of Endobronchial Ultrasound Needle Aspiration With and Without Suction: a Single-center Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphoma; Lung Neoplasms; Tuberculosis; EGF-R Positive Non-Small Cell Lung Cancer; Sarcoidosis; Mediastinal Lymphadenopathy; Hilar Lymphadenopathy; ROS1 Gene Mutation; PDL1 Gene Mutation; ALK Translocation
• Intervention / Treatment: Procedure: No suction EBUS-TBNA; Procedure: Passive suction through dedicated EBUS-TBNA syringe; Procedure: Manual applied suction EBUS-TBNA through a pistol-grip syringe holder

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.

• Study Type: Interventional
• Enrollment (Anticipated): 306
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Gasparini, MD; Phone Number: 0715964353; Email: s.gasparini@univpm.it
• Study Contact Backup: Name: Francesca Gonnelli, MD; Email: francesca.gonnelli@ospedaliriuniti.marche.it

Study Locations

• Italy
  • Ancona, Italy, 60126
    • Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti' Ancona
    • Contact: Francesca Gonnelli, MD; Email: francesca.gonnelli@ospedaliriuniti.marche.it
    • Contact: Stefano Gasparini, MD; Phone Number: 0715934353; Email: s.gasparini@univpm.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: No suction EBUS-TBNA; In this technique the stylet is slowly removed without any kind of device in order to avoid active suction.	Procedure: 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.
ACTIVE_COMPARATOR: Passive suction through dedicated EBUS-TBNA syringe; After rapid stylet removal, suction is applied through a vacuteiner syringe, without active aspiration.	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.
ACTIVE_COMPARATOR: 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.	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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the diagnostic yield of active suction vs passive suction vs no suction EBUS-TBNA in the diagnosis of hilar/mediastinal adenopathies	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%.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adeguacy for molecular assessment in lung cancer	Considering only the lung cancer diagnoses, the sample is considered adeguated is if provides all the available molecular evaluations included PD-L1 iperexpression	36 months
Qualitative evaluation of the sample by the pathologist	The sample is evaluated by a pathologist that provides a semi-quantitative assessment of the sample, through a cell count: the sample is adeguate only if it contains more than diagnostic 100 cells.	36 months

Collaborators and Investigators

• Sponsor: Università Politecnica delle Marche

Publications and helpful links

General Publications

• Labarca G, Folch E, Jantz M, Mehta HJ, Majid A, Fernandez-Bussy S. Adequacy of Samples Obtained by Endobronchial Ultrasound with Transbronchial Needle Aspiration for Molecular Analysis in Patients with Non-Small Cell Lung Cancer. Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Oct;15(10):1205-1216. doi: 10.1513/AnnalsATS.201801-045OC.
• Wahidi MM, Herth F, Yasufuku K, Shepherd RW, Yarmus L, Chawla M, Lamb C, Casey KR, Patel S, Silvestri GA, Feller-Kopman DJ. Technical Aspects of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: CHEST Guideline and Expert Panel Report. Chest. 2016 Mar;149(3):816-35. doi: 10.1378/chest.15-1216. Epub 2016 Jan 12.
• He X, Wu Y, Wang H, Yu G, Xu B, Jia N, Yao Z. Slow-pull capillary technique versus suction technique in endobronchial ultrasound-guided transbronchial needle aspiration for diagnosing diseases involving hilar and mediastinal lymph node enlargement. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620907037. doi: 10.1177/1753466620907037.
• Lin X, Ye M, Li Y, Ren J, Lou Q, Li Y, Jin X, Wang KP, Chen C. Randomized controlled trial to evaluate the utility of suction and inner-stylet of EBUS-TBNA for mediastinal and hilar lymphadenopathy. BMC Pulm Med. 2018 Dec 7;18(1):192. doi: 10.1186/s12890-018-0751-0.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): June 26, 2022
• Study Completion (ANTICIPATED): June 26, 2024

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (ACTUAL): November 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Lung Neoplasms; Tuberculosis; Lymphadenopathy; Sarcoidosis
• Other Study ID Numbers: AspiraTE2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No