Back to resultsEBUS-TBNA Versus EBUS-TBNB
Primary Purpose
Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Carcinoma
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endobronchial ultrasound guided lymph node sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Mediastinal Lymphadenopathy focused on measuring Endobronchial ultrasound, Transbronchial needle aspiration, Transbronchial biopsy forceps, Mediastinal lymphadenopathy, Hilar lymphadenopathy
Eligibility Criteria
Inclusion Criteria:
- Scheduled for EBUS-TBNA as part of clinical care
- Lymph nodes larger than 10mm in diameter
- Age > 18 years
- Able to provide written informed consent
Exclusion Criteria:
- Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
- Inability to obtain informed consent
Sites / Locations
- Thoraxklinik, University of Heidelberg
- Chelsea and Westminster Hospital
- The Royal Brompton Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
EBUS-TBNA
EBUS-TBNB
Arm Description
Sampling using endobronchial ultrasound guided transbronchial needle aspiration
Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.
Outcomes
Primary Outcome Measures
The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below:
Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour.
Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas.
Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium.
Secondary Outcome Measures
The difference in the complication rate between the two study arms
Full Information
NCT ID
NCT01467635
First Posted
November 4, 2011
Last Updated
July 12, 2016
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Chelsea and Westminster NHS Foundation Trust, Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT01467635
Brief Title
EBUS-TBNA Versus EBUS-TBNB
Official Title
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Manufacturer did not develop and deliver the necessary biopsy forceps needles in time
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Chelsea and Westminster NHS Foundation Trust, Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).
The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Carcinoma, Lymphoma, Sarcoidosis, Mycobacterial Disease
Keywords
Endobronchial ultrasound, Transbronchial needle aspiration, Transbronchial biopsy forceps, Mediastinal lymphadenopathy, Hilar lymphadenopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EBUS-TBNA
Arm Type
Active Comparator
Arm Description
Sampling using endobronchial ultrasound guided transbronchial needle aspiration
Arm Title
EBUS-TBNB
Arm Type
Experimental
Arm Description
Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.
Intervention Type
Device
Intervention Name(s)
Endobronchial ultrasound guided lymph node sampling
Other Intervention Name(s)
Olympus EBUS-TBNA needle, Olympus EBUS-TBNB biopsy forceps
Intervention Description
Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.
Primary Outcome Measure Information:
Title
The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
Description
The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below:
Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour.
Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas.
Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
The difference in the complication rate between the two study arms
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled for EBUS-TBNA as part of clinical care
Lymph nodes larger than 10mm in diameter
Age > 18 years
Able to provide written informed consent
Exclusion Criteria:
Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
Inability to obtain informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaid Zoumot, MBBS, MRCP, MSc
Organizational Affiliation
Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pallav L Shah, MD, FRCP
Organizational Affiliation
Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxklinik, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
Facility Name
Chelsea and Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
The Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
12. IPD Sharing Statement
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EBUS-TBNA Versus EBUS-TBNB
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