EBUS-TBNA vs Flex 19G EBUS-TBNA

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02916459
• Other study ID #: 19G 1.1-2016
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2016
• Last updated: February 6, 2017
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: February 2017
• Source: Heidelberg University
• Contact: Felix Herth, Prof. Dr.
• Phone: +49-(0)6221-396-1201
• Email: herth[@]uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lymphadenopathy
• Lymphoma
• Sarcoidosis

Intervention

Device:
• 21G EBUS-TBNA needle

• Flexible 19G EBUS-TBNA needle

Locations

Country	Name	City	State
Germany	Department of Pneumology and Critical Care medicine	Heidelberg	BW

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Olympus Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 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	1 week
Secondary	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
Secondary	The difference in complication rates between the two study arms		1 month
Secondary	The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis		1 week
Secondary	The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma		1 week
Secondary	The difference in sensitivity for detecting sarcoidosis between the two study arms	Sensitivity = True Positives/(True Positives + False Negatives)	1 week
Secondary	The difference in sensitivity for detecting lymphoma between the two study arms	Sensitivity = True Positives/(True Positives + False Negatives)	1 week