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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
250
Department of Pneumology and Critical Care medicine
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGThe difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
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
Time frame: 1 week
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
Time frame: 1 week
The difference in complication rates between the two study arms
Time frame: 1 month
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis
Time frame: 1 week
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma
Time frame: 1 week
The difference in sensitivity for detecting sarcoidosis between the two study arms
Sensitivity = True Positives/(True Positives + False Negatives)
Time frame: 1 week
The difference in sensitivity for detecting lymphoma between the two study arms
Sensitivity = True Positives/(True Positives + False Negatives)
Time frame: 1 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.