A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of Isolated MEDiastinal lymphadenopathY (REMEDY)
18 Years
N/A
Both
Isolated Mediastinal Lymphadenopathy, Sarcoidosis, Tuberculosis, Lung Cancer, Lymphoma
Trial Information
A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of Isolated MEDiastinal lymphadenopathY (REMEDY)
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Number of mediastinoscopies prevented and healthcare costs
Outcome Time Frame:
At diagnosis
Safety Issue:
No
Principal Investigator
Sam Janes, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University College, London
Authority:
United Kingdom: Research Ethics Committee
Study ID:
REMEDY 09/0090
NCT ID:
NCT00932854
Start Date:
July 2009
Completion Date:
October 2011
Related Keywords:
- Isolated Mediastinal Lymphadenopathy
- Sarcoidosis
- Tuberculosis
- Lung Cancer
- Lymphoma
- Mediastinal lymphadenopathy
- EBUS
- Bronchoscopy
- Sarcoidosis
- Lung Neoplasms
- Lymphoma
- Sarcoidosis
- Tuberculosis
- Lymphatic Diseases
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