Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.

Outcome 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.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Zaid Zoumot, MBBS, MRCP, MSc

Investigator Role:

Study Director

Investigator Affiliation:

Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

2011PA002B

NCT ID:

NCT01467635

Start Date:

October 2011

Completion Date:

October 2013

Related Keywords:

• Mediastinal Lymphadenopathy
• Hilar Lymphadenopathy
• Carcinoma
• Lymphoma
• Sarcoidosis
• Mycobacterial Disease
• Endobronchial ultrasound
• Transbronchial needle aspiration
• Transbronchial biopsy forceps
• Mediastinal lymphadenopathy
• Hilar lymphadenopathy
• Carcinoma
• Lymphoma
• Mycobacterium Infections
• Sarcoidosis
• Lymphatic Diseases