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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:


Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • Number of mediastinoscopies prevented and healthcare costs [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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:
  • EBUS-TBNA
  • EBUS-FNA

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University College London Hospitals

Additional 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
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University College London Hospitals:
Mediastinal lymphadenopathy
EBUS
Bronchoscopy
Sarcoidosis

Additional relevant MeSH terms:
Lung Neoplasms
Lymphoma
Sarcoidosis
Tuberculosis
Lymphatic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 31, 2014