Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
250 participants
INTERVENTIONAL
2020-03-02
2021-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EBUS TBNA
Patients will undergo a standard EBUS examination, with sampling using a standard 22G EBUS needle.
EBUS-TBNA
Mediastinal and hilar lymph node sampling using a standard 22G EBUS needle
Acquire TBNB
Patients will undergo a standard EBUS examination, with sampling using an Acquire TBNB needle.
Acquire TBNB
Mediastinal and hilar lymph node sampling using the Acquire TBNB needle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EBUS-TBNA
Mediastinal and hilar lymph node sampling using a standard 22G EBUS needle
Acquire TBNB
Mediastinal and hilar lymph node sampling using the Acquire TBNB needle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Lymph node size ≥5mm on CT scan
3. Age \> 18 years
4. Written informed consent
Exclusion Criteria
2. Inability to obtain informed consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Samuel V Kemp, MBBS
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton and Harefield NHS FT
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Brompton Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
274281
Identifier Type: -
Identifier Source: org_study_id