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A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY) (REMEDY)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Sam Janes, University College London Hospitals.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
University College London Hospitals
Information provided by (Responsible Party):
Sam Janes, University College London Hospitals
ClinicalTrials.gov Identifier:
NCT00932854
First received: July 2, 2009
Last updated: October 17, 2011
Last verified: October 2011
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Purpose
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 | Intervention |
|---|---|
| Isolated Mediastinal Lymphadenopathy Sarcoidosis Tuberculosis Lung Cancer Lymphoma | Procedure: EBUS |
| Study Type: | Interventional |
| Study Design: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Ultrasound
U.S. FDA Resources
Further study details as provided by Sam Janes, University College London Hospitals:
Primary Outcome Measures:
- Number of mediastinoscopies prevented and healthcare costs [ Time Frame: At diagnosis ]
Secondary Outcome Measures:
- Length of hospital stay [ Time Frame: At diagnosis ]
- Sensitivity and false negative rate of endobronchial ultrasound [ Time Frame: At study completion ]
| Estimated Enrollment: | 75 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | October 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00932854
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932854
Locations
| United Kingdom | |
| University College London Hospital | |
| London, United Kingdom, WC1E 5DB | |
Sponsors and Collaborators
University College London Hospitals
Investigators
| Principal Investigator: | Sam Janes, MD PhD | University College, London |
| Study Director: | Neal Navani, MD | Univeristy College London |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sam Janes, Reader in Respiratory Medicine, University College London Hospitals |
| ClinicalTrials.gov Identifier: | NCT00932854 History of Changes |
| Other Study ID Numbers: |
REMEDY 09/0090 |
| Study First Received: | July 2, 2009 |
| Last Updated: | October 17, 2011 |
Keywords provided by Sam Janes, University College London Hospitals:
|
Mediastinal lymphadenopathy EBUS Bronchoscopy Sarcoidosis |
Additional relevant MeSH terms:
|
Tuberculosis Sarcoidosis Lymphatic Diseases Mycobacterium Infections |
Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lymphoproliferative Disorders |
ClinicalTrials.gov processed this record on September 21, 2017