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A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY) (REMEDY)

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ClinicalTrials.gov Identifier: NCT00932854
Recruitment Status : Unknown
Verified October 2011 by Sam Janes, University College London Hospitals.
Recruitment status was:  Active, not recruiting
First Posted : July 3, 2009
Last Update Posted : October 18, 2011
Sponsor:
Information provided by (Responsible Party):
Sam Janes, University College London Hospitals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Isolated Mediastinal Lymphadenopathy Sarcoidosis Tuberculosis Lung Cancer Lymphoma Procedure: EBUS Not Applicable

Detailed Description:
Although the literature is replete with data on the utility of Endobronchial Ultrasound for lung cancer, there are very few data available on its role in the diagnosis of isolated mediastinal lymphadenopathy due to other causes such as sarcoid, tuberculosis or lymphoma. The REMEDY trial aims to evaluate the accuracy of EBUS in this setting and assess any reduction in the number of mediastinoscopies and healthcare costs.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of Isolated MEDiastinal lymphadenopathY (REMEDY)
Study Start Date : July 2009
Actual Primary Completion Date : April 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arms and Interventions
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Arm Intervention/treatment
Experimental: EBUS
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
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.
Other Names:
  • EBUS-TBNA
  • EBUS-FNA


Outcome Measures
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Primary Outcome Measures :
  1. Number of mediastinoscopies prevented and healthcare costs [ Time Frame: At diagnosis ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: At diagnosis ]
  2. Sensitivity and false negative rate of endobronchial ultrasound [ Time Frame: At study completion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients without informed consent, those with anterior mediastinal lesions or with contra-indications to EBUS or mediastinoscopy will be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932854


Locations
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United Kingdom
University College London Hospital
London, United Kingdom, WC1E 5DB
Sponsors and Collaborators
University College London Hospitals
Investigators
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Principal Investigator: Sam Janes, MD PhD University College, London
Study Director: Neal Navani, MD Univeristy College London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sam Janes, Reader in Respiratory Medicine, University College London Hospitals
ClinicalTrials.gov Identifier: NCT00932854    
Other Study ID Numbers: REMEDY 09/0090
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011
Keywords provided by Sam Janes, University College London Hospitals:
Mediastinal lymphadenopathy
EBUS
Bronchoscopy
Sarcoidosis
Additional relevant MeSH terms:
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Tuberculosis
Sarcoidosis
Lymphadenopathy
Mycobacterium Infections
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Lymphoproliferative Disorders
Lymphatic Diseases