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 Lymphadenopathy: a Randomised Trial

Endobronchial ultrasound (EBUS) guided transbronchial needle aspiration (EBUS-TBNA) is an excellent tool for sampling enlarged mediastinal and hilar lymph nodes, but only provides needle aspirate samples which are often adequate for cytological examination only. More advanced histopathological and immunocytopathological assessment of tissue samples, which is particularly important in the diagnosis and staging of cancer, is often not possible with the small cellular samples obtained by EBUS-TBNA. A new transbronchial nodal aspiration needle (the Flex 19G EBUS-TBNA needle) has been developed with a larger needle diameter and more flexibility at the distal end, allowing better access to some lymph nodes stations. This needle can be passed down an EBUS scope and can hypothetically circumvent the deficiencies of EBUS-TBNA highlighted above by providing tissue adequate for histological assessment rather than cytological assessment alone.

This study aims to establish whether the use of the Flex 19G EBUS-TBNA needle can improve the diagnostic yield of EBUS sampling procedures compared to the use of the conventional TBNA needle, thereby allowing more accurate diagnoses and reducing the need repeat procedures or more invasive surgical biopsies, without causing an increase in complication rates. Patients with enlarged mediastinal and hilar lymph nodes referred for EBUS-TBNA will be randomised to have their nodes sampled by either the EBUS-TBNA needle (conventional procedure) or the novel Flex 19G EBUS-TBNA needle. The investigators hope to recruit 250 patients over a 24 month period.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Lung Cancer; Lymphadenopathy; Sarcoidosis
• Intervention / Treatment: Device: Flexible 19G EBUS-TBNA needle; Device: 21G EBUS-TBNA needle

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled for EBUS-TBNA as part of clinical care
• Lymph nodes larger than 10mm in diameter
• Age > 18 years
• Written informed consent

Exclusion Criteria:

• Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
• Inability to obtain informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flex 19G EBUS-TBNA; Mediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle	Device: Flexible 19G EBUS-TBNA needle
Active Comparator: EBUS-TBNA; Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle	Device: 21G EBUS-TBNA needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Sensitivity = True Positives/(True Positives + False Negatives)	1 week
The difference in sensitivity for detecting lymphoma between the two study arms	Sensitivity = True Positives/(True Positives + False Negatives)	1 week

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Collaborators: Olympus Corporation
• Investigators: Principal Investigator: Pallav L Shah, MBBS MD, Royal Brompton and Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): November 14, 2017
• Study Completion (Actual): December 14, 2017

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: EBUS; Lung cancer; Endobronchial ultrasound; TBNA; Mediastinal ymphadenopathy; Hilar lymphadenopathy
• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Lymphadenopathy; Sarcoidosis
• Other Study ID Numbers: 2015LF016B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided