EBUS-TBNA vs Flex 19G EBUS-TBNA

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592837
• Other study ID #: 2015LF016B
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 14, 2017

Study information

• Verified date: May 2018
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 14, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lymphadenopathy
• Lymphoma
• Sarcoidosis

Intervention

Device:
• Flexible 19G EBUS-TBNA needle

• 21G EBUS-TBNA needle

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	Olympus Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The difference in complication rates between the two study arms		1 month
Secondary	The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis		1 week
Secondary	The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma		1 week
Secondary	The difference in sensitivity for detecting sarcoidosis between the two study arms	Sensitivity = True Positives/(True Positives + False Negatives)	1 week
Secondary	The difference in sensitivity for detecting lymphoma between the two study arms	Sensitivity = True Positives/(True Positives + False Negatives)	1 week