Clinical trial NCT02916459: EBUS-TBNA vs Flex 19G EBUS-TBNA
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphadenopathy
Lung Cancer
Sarcoidosis
Lymphoma
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Olympus Corporation
First posted: 2016-09-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
timeFrame: 1 week
Secondary outcomes:
measure: 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
timeFrame: 1 week
measure: The difference in complication rates between the two study arms
timeFrame: 1 month
measure: The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis
timeFrame: 1 week
measure: The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma
timeFrame: 1 week
measure: The difference in sensitivity for detecting sarcoidosis between the two study arms
timeFrame: 1 week
measure: The difference in sensitivity for detecting lymphoma between the two study arms
timeFrame: 1 week
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Pneumology and Critical Care medicine
state: BW
Study officials:
References: