Carcinoma, Hilar Lymphadenopathy, Lymphoma, Mediastinal Lymphadenopathy, Mycobacterial Disease, Sarcoidosis
Conditions
Keywords
Endobronchial ultrasound, Transbronchial needle aspiration, Transbronchial biopsy forceps, Mediastinal lymphadenopathy, Hilar lymphadenopathy
Brief summary
A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB). The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.
Interventions
DEVICEEndobronchial ultrasound guided lymph node sampling
Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.
Sponsors
Chelsea and Westminster NHS Foundation Trust
Heidelberg University
Royal Brompton & Harefield NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for EBUS-TBNA as part of clinical care * Lymph nodes larger than 10mm in diameter * Age \> 18 years * Able to provide written informed consent
Exclusion criteria
* Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia) * Inability to obtain informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms. | 18 months | The definition of a definitive diagnosis is dependant on the diagnosis and is clarified below: * Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour. * Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas. * Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium. |
Secondary
| Measure | Time frame |
|---|---|
| The difference in the complication rate between the two study arms | 24 months |
Countries
Germany, United Kingdom
Outcome results
None listed