Endobronchial Ultrasound Needle Aspiration With and Without Suction

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05110950
• Other study ID #: AspiraTE2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 26, 2024

Study information

• Verified date: May 2022
• Source: Università Politecnica delle Marche
• Contact: Stefano Gasparini, MD
• Phone: 0715964353
• Email: s.gasparini[@]univpm.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 306
• Est. completion date: June 26, 2024
• Est. primary completion date: June 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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..

Locations

Country	Name	City	State
Italy	Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti' Ancona	Ancona

Sponsors (1)

Lead Sponsor	Collaborator
Università Politecnica delle Marche

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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 A — View 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 Met — View 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- — View 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. Che — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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