NCT00932854

Brief Summary

Enlarged glands in the chest (mediastinal lymphadenopathy) is a common problem and may have a variety of different causes. In the past an operation (mediastinoscopy) was required to diagnose the glands. Endobronchial ultrasound (EBUS) is a new procedure that may be able to diagnose these glands without the need for mediastinoscopy. The REMEDY trial aims to examine whether EBUS can reduce the number of mediastinoscopies and healthcare costs in patients with enlarged glands in the chest.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 18, 2011

Status Verified

October 1, 2011

Enrollment Period

1.8 years

First QC Date

July 2, 2009

Last Update Submit

October 17, 2011

Conditions

Isolated Mediastinal LymphadenopathySarcoidosisTuberculosisLung CancerLymphoma

Keywords

Mediastinal lymphadenopathyEBUSBronchoscopySarcoidosis

Outcome Measures

Primary Outcomes (1)

  • Number of mediastinoscopies prevented and healthcare costs

    At diagnosis

Secondary Outcomes (2)

  • Length of hospital stay

    At diagnosis

  • Sensitivity and false negative rate of endobronchial ultrasound

    At study completion

Study Arms (1)

EBUS

EXPERIMENTAL

All patients in the trial will undergo EBUS for the diagnosis of isolated mediastinal lymphadenopathy. If this investigation is negative then the patient will be referred for mediastinoscopy.

Procedure: EBUS

Interventions

EBUSPROCEDURE

Endobronchial ultrasound guided transbronchial needle aspiration will be performed under conscious sedation and as an outpatient procedure. Additional bronchoscopy, transbronchial biopsies and bronchoalveolar lavage will be performed at the investigator's discretion.

Also known as: EBUS-TBNA, EBUS-FNA
EBUS

Eligibility Criteria

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

You may qualify if:

  • Consecutive patients with undiagnosed mediastinal lymphadenopathy (\>1cm in short axis) on CT or PET-CT scan for whom pathological evaluation is clinically indicated.

You may not qualify if:

  • Patients without informed consent, those with anterior mediastinal lesions or with contra-indications to EBUS or mediastinoscopy will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospital

London, London, WC1E 5DB, United Kingdom

Location

Related Publications (1)

  • Navani N, Lawrence DR, Kolvekar S, Hayward M, McAsey D, Kocjan G, Falzon M, Capitanio A, Shaw P, Morris S, Omar RZ, Janes SM; REMEDY Trial Investigators. Endobronchial ultrasound-guided transbronchial needle aspiration prevents mediastinoscopies in the diagnosis of isolated mediastinal lymphadenopathy: a prospective trial. Am J Respir Crit Care Med. 2012 Aug 1;186(3):255-60. doi: 10.1164/rccm.201203-0393OC. Epub 2012 May 31.

    PMID: 22652031DERIVED

MeSH Terms

Conditions

SarcoidosisTuberculosisLung NeoplasmsLymphoma

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeImmunoproliferative Disorders

Study Officials

  • Sam Janes, MD PhD

    University College, London

    PRINCIPAL INVESTIGATOR

  • Neal Navani, MD

    Univeristy College London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Respiratory Medicine

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 3, 2009

Study Start

July 1, 2009

Primary Completion

April 1, 2011

Study Completion

October 1, 2011

Last Updated

October 18, 2011

Record last verified: 2011-10

Locations

GB(1)