EBUS-TBNA Versus EBUS-TBNB

NCT ID: NCT01467635

Last Updated: 2016-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Mediastinal Lymphadenopathy Hilar Lymphadenopathy Carcinoma Lymphoma Sarcoidosis Mycobacterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EBUS-TBNA

Sampling using endobronchial ultrasound guided transbronchial needle aspiration

Group Type ACTIVE_COMPARATOR

Endobronchial ultrasound guided lymph node sampling

Intervention Type DEVICE

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.

EBUS-TBNB

Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.

Group Type EXPERIMENTAL

Endobronchial ultrasound guided lymph node sampling

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Olympus EBUS-TBNA needle Olympus EBUS-TBNB biopsy forceps

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zaid Zoumot, MBBS, MRCP, MSc

Role: STUDY_DIRECTOR

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

Pallav L Shah, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Thoraxklinik, University of Heidelberg

Heidelberg, , Germany

Site Status

Chelsea and Westminster Hospital

London, , United Kingdom

Site Status

The Royal Brompton Hospital

London, , United Kingdom

Site Status

Countries

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Germany United Kingdom

Other Identifiers

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2011PA002B

Identifier Type: -

Identifier Source: org_study_id

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