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EBUS-TBNA Versus EBUS-TBNB

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ClinicalTrials.gov Identifier: NCT01467635
Recruitment Status : Withdrawn (Manufacturer did not develop and deliver the necessary biopsy forceps needles in time)
First Posted : November 9, 2011
Last Update Posted : July 13, 2016
Sponsor:
Collaborators:
Chelsea and Westminster NHS Foundation Trust
Heidelberg University
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

November 4, 2011
November 9, 2011
July 13, 2016
May 2014
July 2016   (Final data collection date for primary outcome measure)
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 ]
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.
Same as current
Complete list of historical versions of study NCT01467635 on ClinicalTrials.gov Archive Site
The difference in the complication rate between the two study arms [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
 
EBUS-TBNA Versus EBUS-TBNB
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

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
  • Mediastinal Lymphadenopathy
  • Hilar Lymphadenopathy
  • Carcinoma
  • Lymphoma
  • Sarcoidosis
  • Mycobacterial Disease
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
  • Active Comparator: EBUS-TBNA
    Sampling using endobronchial ultrasound guided transbronchial needle aspiration
    Intervention: Device: Endobronchial ultrasound guided lymph node sampling
  • Experimental: EBUS-TBNB
    Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.
    Intervention: Device: Endobronchial ultrasound guided lymph node sampling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
250
July 2016
July 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
 
NCT01467635
2011PA002B
No
Not Provided
Not Provided
Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
  • Chelsea and Westminster NHS Foundation Trust
  • Heidelberg University
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
Royal Brompton & Harefield NHS Foundation Trust
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP