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Endobronchial Ultrasound Needle Aspiration With and Without Suction

Primary Purpose

Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Lymphoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
No suction EBUS-TBNA
Passive suction through dedicated EBUS-TBNA syringe
Manual applied suction EBUS-TBNA through a pistol-grip syringe holder
Sponsored by
Università Politecnica delle Marche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mediastinal Lymphadenopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti' Ancona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

No suction EBUS-TBNA

Passive suction through dedicated EBUS-TBNA syringe

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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
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.

Full Information

First Posted
October 27, 2021
Last Updated
May 25, 2022
Sponsor
Università Politecnica delle Marche
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1. Study Identification

Unique Protocol Identification Number
NCT05110950
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 26, 2022 (Anticipated)
Study Completion Date
June 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Politecnica delle Marche

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Both the pathologist and the patient are not aware of the type of adopted aspiration technique
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No suction EBUS-TBNA
Arm Type
Active Comparator
Arm Description
In this technique the stylet is slowly removed without any kind of device in order to avoid active suction.
Arm Title
Passive suction through dedicated EBUS-TBNA syringe
Arm Type
Active Comparator
Arm Description
After rapid stylet removal, suction is applied through a vacuteiner syringe, without active aspiration.
Arm Title
Manual applied suction EBUS-TBNA through a pistol-grip syringe holder
Arm Type
Active Comparator
Arm Description
After rapid stylet removal, suction is applied through Cameco syringe pistol, that can apply active suction manually.
Intervention Type
Procedure
Intervention Name(s)
No suction EBUS-TBNA
Intervention Description
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
Intervention Name(s)
Passive suction through dedicated EBUS-TBNA syringe
Intervention Description
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
Intervention Name(s)
Manual applied suction EBUS-TBNA through a pistol-grip syringe holder
Intervention Description
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..
Primary Outcome Measure Information:
Title
To compare the diagnostic yield of active suction vs passive suction vs no suction EBUS-TBNA in the diagnosis of hilar/mediastinal adenopathies
Description
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%.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Adeguacy for molecular assessment in lung cancer
Description
Considering only the lung cancer diagnoses, the sample is considered adeguated is if provides all the available molecular evaluations included PD-L1 iperexpression
Time Frame
36 months
Title
Qualitative evaluation of the sample by the pathologist
Description
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.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Gasparini, MD
Phone
0715964353
Email
s.gasparini@univpm.it
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Gonnelli, MD
Email
francesca.gonnelli@ospedaliriuniti.marche.it
Facility Information:
Facility Name
Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti' Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Gasparini, MD
Phone
0715934353
Email
s.gasparini@univpm.it
First Name & Middle Initial & Last Name & Degree
Francesca Gonnelli, MD
Email
francesca.gonnelli@ospedaliriuniti.marche.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30011388
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.
Results Reference
result
PubMed Identifier
26402427
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.
Results Reference
result
PubMed Identifier
32103709
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.
Results Reference
result
PubMed Identifier
30526587
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.
Results Reference
result

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Endobronchial Ultrasound Needle Aspiration With and Without Suction

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