EBUS-TBNA vs Flex 19G EBUS-TBNA

Not Applicable

• Conditions: Lymphadenopathy; Lung Cancer; Sarcoidosis; Lymphoma
• Interventions: Device: 21G EBUS-TBNA needle; Device: Flexible 19G EBUS-TBNA needle

• Registration Number: NCT02916459
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Study Start: 2016-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-07
• Primary Completion: 2018-09
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBUS-TBNA	21G EBUS-TBNA needle	Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle
Flex 19G EBUS-TBNA	Flexible 19G EBUS-TBNA needle	Mediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma	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)

Trial Locations

Locations (1)

Department of Pneumology and Critical Care medicine; 🇩🇪 Heidelberg, BW, Germany