Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mediastinal Lymphadenopathy
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Locations
- 3
- Primary Endpoint
- The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
Time Frame: 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 Outcomes
- The difference in the complication rate between the two study arms(24 months)