Clinical trial NCT05110950: Endobronchial Ultrasound Needle Aspiration With and Without Suction
Official title: Diagnostic Accuracy of Endobronchial Ultrasound Needle Aspiration With and Without Suction: a Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: To compare the diagnostic yield of active suction vs passive suction vs no suction EBUS-TBNA in the diagnosis of hilar/mediastinal adenopathies
timeFrame: 36 months
Secondary outcomes:
measure: Adeguacy for molecular assessment in lung cancer
timeFrame: 36 months
measure: Qualitative evaluation of the sample by the pathologist
timeFrame: 36 months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti' Ancona
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.