Mediastinal Lymphadenopathy Clinical Trial
Official title:
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus the Endobronchial Ultrasound Transbronchial Needle Biopsy Using the Acquire Needle in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
This study aims to determine whether a new type of needle used for sampling lymph nodes (glands) around the airways of the lung, during a procedure called an endobronchial ultrasound (EBUS, provides more or better quality tissue to allow a definite diagnosis to be made than with the current standard sampling needle. Two hundred and fifty patients will be randomised to procedures using either the new or standard needle, and the results compared.
The causes of mediastinal lymphadenopathy include infection, reactive lymphadenopathy,
granulomatous disorders, and malignancy (metastases from various primaries, lymphoma,
thymoma, neurogenic tumours). Radiological appearances are usually inadequate at providing a
definitive diagnosis. In granulomatous disorders such as sarcoidosis as well as certain
infections including tuberculosis, there is frequently mediastinal or hilar lymph node
involvement without evidence of disease activity in other organs or lymph node groups. In
malignancy, the metastatic involvement of lymph nodes has important prognostic significance.
However, lymph node enlargement as seen on computerised tomography (CT) scanning is a poor
predictor of disease involvement, and positron emission tomography (PET) of the mediastinum
has a 10-15% false positive rate. Adequate mediastinal lymph node sampling is therefore
essential in order to reach a definitive diagnosis and obtain satisfactory staging
information.
Mediastinal nodal sampling has traditionally been performed using invasive surgical
techniques which carry significant morbidity and mortality. These procedures (cervical
mediastinoscopy, anterior mediastinotomy) require general anaesthesia and a hospital
inpatient stay. Some patients with significant comorbidities are therefore not considered for
these procedures as they are deemed unfit for anaesthesia. Safer, less invasive, and more
cost-effective procedures using endoscopic ultrasonography to guide needle aspiration of
mediastinal lymph nodes have been developed. Endobronchial ultrasound (EBUS) used to guide
transbronchial needle aspiration (TBNA) of mediastinal masses has, in a matter of a few
years, established itself firmly within the diagnostic and staging algorithm for lung cancer,
and also in the diagnosis of other causes of mediastinal and hilar lymphadenopathy such as
sarcoidosis and tuberculosis. A wide range of studies has demonstrated the effectiveness and
safety of this technique, with various studies reporting sensitivities of between 67% and
92%3.
EBUS-guided needle aspirates performed with 22 gauge needles yield cytological specimens
which are often inadequate at providing a firm diagnosis, or at confidently excluding other
malignancies such as lymphoma. Immunohistochemistry and mutational analysis are today playing
a more important role in the treatment of lung cancer. There is an increasing need for larger
tissue samples and ideally biopsy material to enable advanced histopathological examination
of specimens. For example, a substantial percentage of lung cancers express cell surface
epidermal growth factor receptors (EGFRs). Small molecules designed to inhibit the tyrosine
kinase (TK) domain of the EGFR, such as gefitinib and erlotinib, have demonstrated biologic
and clinical responses in patients with mutations within the EGFR-TK domain. These TK
inhibitors are now an important component of the armamentarium of the thoracic oncologist in
the treatment of lung cancer. It has therefore become essential to establish the EGFR
mutation status of lung cancers before consideration of treatment. Mutations of the KRAS gene
in lung cancer patients have been shown to confer resistance to both erlotinib and gefitinib,
adding to the importance of testing tissue samples for these mutations as well. In the past,
tests for EGFR and KRAS gene mutations could only be performed on block tumours post
resection, however advances in molecular biology in recent years have led to the ability to
test small biopsy specimens for such mutations by polymerase chain reaction (PCR) analysis,
fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC). EBUS-TBNA, however,
can only provide needle aspirates. These can provide samples adequate for cytological
assessment, but do not always contain sufficient material to enable the formation of a cell
block, thereby precluding histological assessment. Larger sized core tissue biopsy specimens
are therefore likely to help in the histopathological assessment of lung cancer, and also in
the diagnosis of sarcoidosis, lymphoma and other causes of mediastinal lymphadenopathy. This
is likely to become even more important in the future as new clinically relevant genetic
mutations are identified, and appropriate tests developed.
A novel transbronchial needle has been developed. This franseen needle has a crown tipped
needle with three symmetrical cutting heels placed in a circumferential pattern designed with
the intent to capture more tissue (figure 1). This needle tip was originally designed for use
in interventional radiology, and is now the one of the leading designs used in endoscopic
ultrasound of the gastrointestinal tract. This new needle can be passed down an EBUS scope
and can hypothetically circumvent the deficiencies of EBUS-TBNA highlighted above by
providing greater tissue volume for histological assessment and any subsequent molecular and
genetic testing.
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