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Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB)

This study is currently recruiting participants.
Verified November 2011 by Royal Brompton & Harefield NHS Foundation Trust
Sponsor:
Collaborators:
Chelsea and Westminster NHS Foundation Trust
University of Heidelberg
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01467635
First received: November 4, 2011
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Mediastinal Lymphadenopathy
Hilar Lymphadenopathy
Carcinoma
Lymphoma
Sarcoidosis
Mycobacterial Disease
 Device: Endobronchial ultrasound guided lymph node sampling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EBUS-TBNA
Sampling using endobronchial ultrasound guided transbronchial needle aspiration
 Device: Endobronchial ultrasound guided lymph node sampling
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.
Other Names:
  • Olympus EBUS-TBNA needle
  • Olympus EBUS-TBNB biopsy forceps
Experimental: EBUS-TBNB
Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.
 Device: Endobronchial ultrasound guided lymph node sampling
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.
Other Names:
  • Olympus EBUS-TBNA needle
  • Olympus EBUS-TBNB biopsy forceps

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467635

Contacts
Contact: Zaid Zoumot, MBBS, MRCP, MSc +442073518029 zzoumot@doctors.org.uk
Contact: Pallav L Shah, MD FRCP +442073518021 pallav.shah@imperial.ac.uk

Locations
Germany
Thoraxklinik, University of Heidelberg Not yet recruiting
Heidelberg, Germany, D-69126
Contact: Felix JF Herth, MD, PhD, FCCP     +4962213961200     Felix.Herth@thoraxklinik-heidelberg.de    
Principal Investigator: Felix JF Herth, MD, PhD, FCCP            
United Kingdom
The Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Contact: Zaid Zoumot, MBBS, MRCP, MSc     +442073518029     zzoumot@doctors.org.uk    
Contact: Pallav L Shah, MD, FRCP     +442073518021     pallav.shah@imperial.ac.uk    
Sub-Investigator: Zaid Zoumot, MBBS, MRCP, MSc            
Principal Investigator: Pallav L Shah, MD, FRCP            
Chelsea and Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
Contact: Zaid Zoumot, MBBS, MRCP, MSc     +442073518029     zzoumot@doctors.org.uk    
Contact: Pallav L Shah, MD, FRCP     +442073518021     pallav.shah@imperial.ac.uk    
Sub-Investigator: Zaid Zoumot, MBBS, MRCP, MSc            
Principal Investigator: Pallav L Shah, MD, FRCP            
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Chelsea and Westminster NHS Foundation Trust
University of Heidelberg
Investigators
Study Director: Zaid Zoumot, MBBS, MRCP, MSc Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation Trust
Principal Investigator: Pallav L Shah, MD, FRCP Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01467635     History of Changes
Other Study ID Numbers: 2011PA002B
Study First Received: November 4, 2011
Last Updated: November 7, 2011
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Endobronchial ultrasound
Transbronchial needle aspiration
Transbronchial biopsy forceps
Mediastinal lymphadenopathy
Hilar lymphadenopathy

Additional relevant MeSH terms:
Lymphatic Diseases
Carcinoma
Lymphoma
Mycobacterium Infections
Sarcoidosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 22, 2013