NCT01467635

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
2.5 years until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

November 4, 2011

Last Update Submit

July 12, 2016

Conditions

Mediastinal LymphadenopathyHilar LymphadenopathyCarcinomaLymphomaSarcoidosisMycobacterial Disease

Keywords

Endobronchial ultrasoundTransbronchial needle aspirationTransbronchial biopsy forcepsMediastinal lymphadenopathyHilar lymphadenopathy

Outcome Measures

Primary Outcomes (1)

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

    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.

    18 months

Secondary Outcomes (1)

  • The difference in the complication rate between the two study arms

    24 months

Study Arms (2)

EBUS-TBNA

ACTIVE COMPARATOR

Sampling using endobronchial ultrasound guided transbronchial needle aspiration

Device: Endobronchial ultrasound guided lymph node sampling

EBUS-TBNB

EXPERIMENTAL

Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle.

Device: Endobronchial ultrasound guided lymph node sampling

Interventions

Endobronchial ultrasound guided lymph node samplingDEVICE

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.

Also known as: Olympus EBUS-TBNA needle, Olympus EBUS-TBNB biopsy forceps
EBUS-TBNAEBUS-TBNB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
  • Inability to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Thoraxklinik, University of Heidelberg

Heidelberg, D-69126, Germany

Location

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

The Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

CarcinomaLymphomaSarcoidosisMycobacterium Infections

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHypersensitivity, DelayedHypersensitivityActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Zaid Zoumot, MBBS, MRCP, MSc

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

    STUDY DIRECTOR

  • Pallav L Shah, MD, FRCP

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 9, 2011

Study Start

May 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 13, 2016

Record last verified: 2016-07

Locations

DE(1)GB(2)