Clinical Trials Directory

Trials / Unknown

UnknownNCT05110950

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
306 (estimated)
Sponsor
Università Politecnica delle Marche · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURENo suction EBUS-TBNAThe 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.
PROCEDUREPassive suction through dedicated EBUS-TBNA syringeThe 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.
PROCEDUREManual applied suction EBUS-TBNA through a pistol-grip syringe holderThe 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..

Timeline

Start date
2022-06-01
Primary completion
2022-06-26
Completion
2024-06-26
First posted
2021-11-08
Last updated
2022-05-26

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05110950. Inclusion in this directory is not an endorsement.