EBUS-TBNA vs Acquire TBNB
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus the Endobronchial Ultrasound Transbronchial Needle Biopsy Using the Acquire Needle in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
1 other identifier
interventional
250
1 country
1
Brief Summary
This study aims to determine whether a new type of needle used for sampling lymph nodes (glands) around the airways of the lung, during a procedure called an endobronchial ultrasound (EBUS, provides more or better quality tissue to allow a definite diagnosis to be made than with the current standard sampling needle. Two hundred and fifty patients will be randomised to procedures using either the new or standard needle, and the results compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedStudy Start
First participant enrolled
March 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedDecember 18, 2019
December 1, 2019
12 months
December 12, 2019
December 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The difference in cell volume of cancer or other diagnostic tissue obtained between the two study arms
1 week
Secondary Outcomes (7)
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 month
The difference between the two study arms in the amount of DNA obtained.
1 month
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 month
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma.
1 month
- +2 more secondary outcomes
Study Arms (2)
EBUS TBNA
ACTIVE COMPARATORPatients will undergo a standard EBUS examination, with sampling using a standard 22G EBUS needle.
Acquire TBNB
EXPERIMENTALPatients will undergo a standard EBUS examination, with sampling using an Acquire TBNB needle.
Interventions
Mediastinal and hilar lymph node sampling using the Acquire TBNB needle
Eligibility Criteria
You may qualify if:
- Scheduled for EBUS-TBNA as part of clinical care
- Lymph node size ≥5mm on CT scan
- Age \> 18 years
- Written informed consent
You may not qualify if:
- Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia, other bleeding diathesis)
- Inability to obtain informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel V Kemp, MBBS
Royal Brompton and Harefield NHS FT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 16, 2019
Study Start
March 2, 2020
Primary Completion
March 1, 2021
Study Completion
August 1, 2021
Last Updated
December 18, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share