Lung Cancer, Lymphadenopathy, Lymphoma, Sarcoidosis
Conditions
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.
Interventions
Sponsors
Olympus Corporation
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Scheduled for EBUS-TBNA as part of clinical care 2. Lymph nodes larger than 10mm in diameter 3. Age \> 18 years 4. written informed consent
Exclusion criteria
1. Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia) 2. Inability to obtain informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 the percentage of lymph nodes sampled where enough tissue is obtained for complete immunohistochemical and genetic mutation analysis | 1 week | — |
| The difference in sensitivity for detecting sarcoidosis between the two study arms | 1 week | Sensitivity = True Positives/(True Positives + False Negatives) |
| The difference in sensitivity for detecting lymphoma between the two study arms | 1 week | Sensitivity = True Positives/(True Positives + False Negatives) |
| The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma | 1 week | — |
Countries
Germany
Contacts
Primary ContactFelix Herth, Prof. Dr.
Outcome results
None listed