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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University College London Hospitals.
Recruitment status was  Active, not recruiting
Sponsor:
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

July 2, 2009
October 17, 2011
July 2009
April 2011   (final data collection date for primary outcome measure)
Number of mediastinoscopies prevented and healthcare costs [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00932854 on ClinicalTrials.gov Archive Site
  • Length of hospital stay [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
  • Sensitivity and false negative rate of endobronchial ultrasound [ Time Frame: At study completion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY)
A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of Isolated MEDiastinal lymphadenopathY (REMEDY)

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Isolated Mediastinal Lymphadenopathy
  • Sarcoidosis
  • Tuberculosis
  • Lung Cancer
  • Lymphoma
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
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.
Intervention: Procedure: EBUS
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. Epub 2012 May 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
October 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00932854
REMEDY 09/0090
No
Sam Janes, University College London Hospitals
University College London Hospitals
Not Provided
Principal Investigator: Sam Janes, MD PhD University College, London
Study Director: Neal Navani, MD Univeristy College London
University College London Hospitals
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP