Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lung Neoplasms

Lymphoma

Lymphadenopathy

Sarcoidosis

Lymphoproliferative Disorders

Lymphatic Diseases

Hypersensitivity

Hypersensitivity, Delayed

Lymphosarcoma

Mediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle

Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle

Flexible 19G EBUS-TBNA needle

21G EBUS-TBNA needle

Pallav L Shah, MBBS MD

Endobronchial ultrasound (EBUS) guided transbronchial needle aspiration (EBUS-TBNA) is an excellent tool for sampling enlarged mediastinal and hilar lymph nodes, but only provides needle aspirate samples which are often adequate for cytological examination only. More advanced histopathological and immunocytopathological assessment of tissue samples, which is particularly important in the diagnosis and staging of cancer, is often not possible with the small cellular samples obtained by EBUS-TBNA. A new transbronchial nodal aspiration needle (the Flex 19G EBUS-TBNA needle) has been developed with a larger needle diameter and more flexibility at the distal end, allowing better access to some lymph nodes stations. This needle can be passed down an EBUS scope and can hypothetically circumvent the deficiencies of EBUS-TBNA highlighted above by providing tissue adequate for histological assessment rather than cytological assessment alone.

This study aims to establish whether the use of the Flex 19G EBUS-TBNA needle can improve the diagnostic yield of EBUS sampling procedures compared to the use of the conventional TBNA needle, thereby allowing more accurate diagnoses and reducing the need repeat procedures or more invasive surgical biopsies, without causing an increase in complication rates. Patients with enlarged mediastinal and hilar lymph nodes referred for EBUS-TBNA will be randomised to have their nodes sampled by either the EBUS-TBNA needle (conventional procedure) or the novel Flex 19G EBUS-TBNA needle. The investigators hope to recruit 250 patients over a 24 month period.

EBUS-TBNA vs Flex 19G EBUS-TBNA

Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Flexible 19G Endobronchial Ultrasound Transbronchial Needle (Flex 19G EBUS-TBNA) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial

Both specimens (cell pellet and tissue fragments) will be assessed by means of a semiquantitative assessment of material (normal lymph node or lesional tissue) present using the formal scoring system described by Mair.

Sensitivity = True Positives/(True Positives + False Negatives)

Olympus Corporation

Royal Brompton & Harefield NHS Foundation Trust

Infections

Symptoms and General Pathology

Tuberculosis

Communicable Diseases

Mycobacterium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.

Rapid on-site cytopathologic evaluation (ROSE)

TBNA

Marco Patelli, MD

The purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy.

Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy

Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.

Maggiore Bellaria Hospital, Bologna

Marco Patelli

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
EBUS-TBNA vs Flex 19G EBUS-TBNA	NCT02592837	Lymphadenopathy Lung Cancer Sarcoidosis Lymphoma	Flexible 19G EB... 21G EBUS-TBNA n...	18 Years -	Royal Brompton & Harefield NHS Foundation Trust
Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy	NCT00915330	Lung Cancer Sarcoidosis Tuberculosis	Rapid on-site c... TBNA	18 Years - 90 Years	Maggiore Bellaria Hospital, Bologna

Spots Global Cancer Trial Database for hilar lymphadenopathy