Felix Herth, Prof. Dr. Kontakt: Phone: +49-(0)6221-396-1201 E-Mail: herth@uni-heidelberg.de» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Department of Pneumology and Critical Care medicine 69190 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-Maps Ansprechpartner: Felix JF Herth, MD, PhD Phone: +49 6221 396 Phone (ext.): 1200 E-Mail: felix.herth@thoraxklinik-heidelberg.de» Ansprechpartner anzeigen
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.
1. 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 outcome:
1. 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)
2. The difference in complication rates between the two study arms (Time Frame - 1 month)
3. The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis (Time Frame - 1 week)
4. The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma (Time Frame - 1 week)
5. The difference in sensitivity for detecting sarcoidosis between the two study arms (Time Frame - 1 week): Sensitivity = True Positives/(True Positives + False Negatives)
6. The difference in sensitivity for detecting lymphoma between the two study arms (Time Frame - 1 week): Sensitivity = True Positives/(True Positives + False Negatives)
