NCT02916459

EBUS-TBNA vs Flex 19G EBUS-TBNA

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphadenopathy
• Lung Cancer
• Sarcoidosis
• Lymphoma

Interventions

Type	Name	Description
DEVICE	21G EBUS-TBNA needle
DEVICE	Flexible 19G EBUS-TBNA needle

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-09-01
• Completion: 2018-10-01
• First posted: 2016-09-27
• Last updated: 2017-02-07

Locations

1 site across 1 country: Germany