EBUS-TBNA Versus EBUS-TBNB

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Royal Brompton & Harefield NHS Foundation Trust
Sponsor:
Collaborators:
Chelsea and Westminster NHS Foundation Trust
Heidelberg University
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01467635
First received: November 4, 2011
Last updated: June 2, 2014
Last verified: June 2014
  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:


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: May 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Heidelberg University
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: June 2, 2014
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:
Sarcoidosis
Mycobacterium Infections
Lymphoproliferative Disorders
Lymphatic Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014