EBUS-TBNA Versus EBUS-TBNB

Not Applicable

Withdrawn

• Conditions: Sarcoidosis; Mediastinal Lymphadenopathy; Hilar Lymphadenopathy; Mycobacterial Disease; Carcinoma; Lymphoma
• Interventions: Device: Endobronchial ultrasound guided lymph node sampling

• Registration Number: NCT01467635
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-09
• Study Start: 2014-05
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBUS-TBNA	Endobronchial ultrasound guided lymph node sampling	Sampling using endobronchial ultrasound guided transbronchial needle aspiration
EBUS-TBNB	Endobronchial ultrasound guided lymph node sampling	Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The difference in the complication rate between the two study arms	24 months

Trial Locations

Locations (3)

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom

The Royal Brompton Hospital; 🇬🇧 London, United Kingdom

Thoraxklinik, University of Heidelberg; 🇩🇪 Heidelberg, Germany