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 Lymph-adenopathy: a Randomised Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphadenopathy
- Sponsor
- Heidelberg University
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a prospective randomised diagnostic clinical study to determine whether the use of a new flexible sampling needle can improve the yield of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA). Patients undergoing EBUS-TBNA for clinical reasons as deemed necessary by the managing physician or multidisciplinary team will be randomised to undergo either EBUS-TBNA or Flex 19G EBUS-TBNA. The procedure will be performed under local anaesthesia using conscious sedation or general anaesthesia according to usual practice at the trial centre. Specimens will be placed in saline and formalin and forwarded to the pathology laboratory. The specimens will be spun down to create a cell pellet which will undergo cytological and histological examination as per usual protocol at the trial centre.The pathologist, who will be blinded as to which technique was used to obtain the sample, will grade the quality, quantity, and cellularity of the specimens.
Investigators
Felix JF Herth
Prof. Dr. med.
Heidelberg University
Eligibility Criteria
Inclusion Criteria
- •Scheduled for EBUS-TBNA as part of clinical care
- •Lymph nodes larger than 10mm in diameter
- •Age \> 18 years
- •written informed consent
Exclusion Criteria
- •Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
- •Inability to obtain informed consent
Outcomes
Primary Outcomes
The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
Time Frame: 1 week
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
Secondary Outcomes
- The difference between the two study arms in the percentage of lymph nodes sampled where enough tissue is obtained for complete immunohistochemical and genetic mutation analysis(1 week)
- The difference in complication rates between the two study arms(1 month)
- The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis(1 week)
- The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma(1 week)
- The difference in sensitivity for detecting sarcoidosis between the two study arms(1 week)
- The difference in sensitivity for detecting lymphoma between the two study arms(1 week)