EBUS-TBNA vs Flex 19G EBUS-TBNA

Heidelberg University

Status: Unknown

Conditions: Sarcoidosis; Lung Cancer; Lymphoma; Lymphadenopathy

Treatments: Device: 21G EBUS-TBNA needle; Device: Flexible 19G EBUS-TBNA needle

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02916459

19G 1.1-2016

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

EBUS-TBNA

Active Comparator group

Description:

Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle

Treatment:

Device: 21G EBUS-TBNA needle

Flex 19G EBUS-TBNA

Experimental group

Description:

Mediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle

Treatment:

Device: Flexible 19G EBUS-TBNA needle