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EBUS-TBNA Versus EBUS-TBNB

This study has been withdrawn prior to enrollment.
(Manufacturer did not develop and deliver the necessary biopsy forceps needles in time)
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: July 12, 2016
Last verified: July 2016
  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 ]

Enrollment: 0
Study Start Date: May 2014
Estimated Study Completion Date: July 2016
Primary Completion Date: July 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   (Adult, Senior)
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

Locations
Germany
Thoraxklinik, University of Heidelberg
Heidelberg, Germany, D-69126
United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
The Royal Brompton Hospital
London, United Kingdom, SW3 6NP
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

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: July 12, 2016
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 December 09, 2016