EBUS-TBNA Versus EBUS-TBNB

NCT01467635 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-07-13

No results posted yet for this study

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.

Conditions

Mediastinal Lymphadenopathy
Hilar Lymphadenopathy
Carcinoma
Lymphoma
Sarcoidosis
Mycobacterial Disease

Interventions

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.

Sponsors & Collaborators

Chelsea and Westminster NHS Foundation Trust
collaborator OTHER
Heidelberg University
collaborator OTHER
Royal Brompton & Harefield NHS Foundation Trust
lead OTHER

Principal Investigators

Zaid Zoumot, MBBS, MRCP, MSc · Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation Trust
Pallav L Shah, MD, FRCP · Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust

Study Design

Allocation: RANDOMIZED
Purpose: DIAGNOSTIC
Masking: DOUBLE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2014-05-31
Primary Completion: 2016-07-31
Completion: 2016-07-31

Countries

Germany
United Kingdom

Study Locations

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Entities

Diseases

Lymphoma