EBUS-TBNA Versus EBUS-TBNB

Royal Brompton & Harefield NHS Foundation Trust

Status: Withdrawn

Conditions: Hilar Lymphadenopathy; Sarcoidosis; Mediastinal Lymphadenopathy; Mycobacterial Disease; Carcinoma; Lymphoma

Treatments: Device: Endobronchial ultrasound guided lymph node sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT01467635

2011PA002B

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

EBUS-TBNA

Active Comparator group

Description:

Sampling using endobronchial ultrasound guided transbronchial needle aspiration

Treatment:

Device: Endobronchial ultrasound guided lymph node sampling

EBUS-TBNB

Experimental group

Description:

Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.

Treatment:

Device: Endobronchial ultrasound guided lymph node sampling