EBUS-TBNA vs Flex 19G EBUS-TBNA

NCT02592837 | Completed

• 1 other identifier: 2015LF016B
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphadenopathy; Lung Cancer; Sarcoidosis; Lymphoma

Keywords

Endobronchial ultrasound; EBUS; TBNA; Mediastinal ymphadenopathy; Hilar lymphadenopathy; Lung cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Flex 19G EBUS-TBNA

EXPERIMENTAL

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

Device: Flexible 19G EBUS-TBNA needle

EBUS-TBNA

ACTIVE COMPARATOR

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

Device: 21G EBUS-TBNA needle

Interventions

Flexible 19G EBUS-TBNA needle DEVICE

Flex 19G EBUS-TBNA

21G EBUS-TBNA needle DEVICE

EBUS-TBNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Olympus Corporation: collaborator

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Lymphadenopathy; Lung Neoplasms; Sarcoidosis; Lymphoma

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Neoplasms by Histologic Type; Immunoproliferative Disorders

Study Officials

• Pallav L Shah, MBBS MD

  Royal Brompton and Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 30, 2015
• Study Start: May 1, 2016
• Primary Completion: November 14, 2017
• Study Completion: December 14, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

GB (1)