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

Not Applicable

• Conditions: Isolated Mediastinal Lymphadenopathy; Sarcoidosis; Tuberculosis; Lung Cancer; Lymphoma
• Interventions: Procedure: EBUS

• Registration Number: NCT00932854
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Primary Completion: 2011-04
• Status Verified: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-17
• Last Update Posted: 2011-10-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EBUS	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.

Primary Outcome Measures

Name	Time	Method
Number of mediastinoscopies prevented and healthcare costs	At diagnosis

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	At diagnosis
Sensitivity and false negative rate of endobronchial ultrasound	At study completion

Trial Locations

Locations (1)

University College London Hospital; 🇬🇧 London, United Kingdom