Back to resultsA Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY) (REMEDY)
Primary Purpose
Isolated Mediastinal Lymphadenopathy, Sarcoidosis, Tuberculosis
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EBUS
Sponsored by
About this trial
This is an interventional diagnostic trial for Isolated Mediastinal Lymphadenopathy focused on measuring Mediastinal lymphadenopathy, EBUS, Bronchoscopy, Sarcoidosis
Eligibility 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.
Sites / Locations
- University College London Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EBUS
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of mediastinoscopies prevented and healthcare costs
Secondary Outcome Measures
Length of hospital stay
Sensitivity and false negative rate of endobronchial ultrasound
Full Information
NCT ID
NCT00932854
First Posted
July 2, 2009
Last Updated
October 17, 2011
Sponsor
University College London Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT00932854
Brief Title
A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY)
Acronym
REMEDY
Official Title
A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of Isolated MEDiastinal lymphadenopathY (REMEDY)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College London Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Isolated Mediastinal Lymphadenopathy, Sarcoidosis, Tuberculosis, Lung Cancer, Lymphoma
Keywords
Mediastinal lymphadenopathy, EBUS, Bronchoscopy, Sarcoidosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EBUS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
EBUS
Other Intervention Name(s)
EBUS-TBNA, EBUS-FNA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of mediastinoscopies prevented and healthcare costs
Time Frame
At diagnosis
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
At diagnosis
Title
Sensitivity and false negative rate of endobronchial ultrasound
Time Frame
At study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Janes, MD PhD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neal Navani, MD
Organizational Affiliation
Univeristy College London
Official's Role
Study Director
Facility Information:
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
WC1E 5DB
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22652031
Citation
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.
Results Reference
derived
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A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY)
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