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

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

Sponsors

Lead sponsor: University College London Hospitals

Source University College London Hospitals
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.

Overall Status Unknown status
Start Date July 2009
Completion Date October 2011
Primary Completion Date April 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of mediastinoscopies prevented and healthcare costs At diagnosis
Secondary Outcome
Measure Time Frame
Length of hospital stay At diagnosis
Sensitivity and false negative rate of endobronchial ultrasound At study completion
Enrollment 75
Condition
Intervention

Intervention type: Procedure

Intervention name: EBUS

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.

Arm group label: EBUS

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility University College London Hospital
Location Countries

United Kingdom

Verification Date

October 2011

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University College London Hospitals

Investigator full name: Sam Janes

Investigator title: Reader in Respiratory Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: EBUS

Arm group type: Experimental

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.

Acronym REMEDY
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov