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
1 other identifier
interventional
306
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2021
CompletedFirst Posted
Study publicly available on registry
November 8, 2021
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2024
CompletedMay 26, 2022
May 1, 2022
25 days
October 27, 2021
May 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Adeguacy for molecular assessment in lung cancer
36 months
Qualitative evaluation of the sample by the pathologist
36 months
Study Arms (3)
No suction EBUS-TBNA
ACTIVE COMPARATORIn this technique the stylet is slowly removed without any kind of device in order to avoid active suction.
Passive suction through dedicated EBUS-TBNA syringe
ACTIVE COMPARATORAfter rapid stylet removal, suction is applied through a vacuteiner syringe, without active aspiration.
Manual applied suction EBUS-TBNA through a pistol-grip syringe holder
ACTIVE COMPARATORAfter rapid stylet removal, suction is applied through Cameco syringe pistol, that can apply active suction manually.
Interventions
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.
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.
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..
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- coagulopathy or bleeding diathesis that cannot be corrected;
- severe refractory hypoxemia;
- unstable hemodynamic status;
- inability to give an informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti' Ancona
Ancona, 60126, Italy
Related Publications (4)
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.
PMID: 30011388RESULTWahidi 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.
PMID: 26402427RESULTHe 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.
PMID: 32103709RESULTLin 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.
PMID: 30526587RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Both the pathologist and the patient are not aware of the type of adopted aspiration technique
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 27, 2021
First Posted
November 8, 2021
Study Start
June 1, 2022
Primary Completion
June 26, 2022
Study Completion
June 26, 2024
Last Updated
May 26, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share