Overview

This trial is active, not recruiting.

Conditions isolated mediastinal lymphadenopathy, sarcoidosis, tuberculosis, lung cancer, lymphoma
Treatment ebus
Sponsor University College London Hospitals
Start date July 2009
End date April 2011
Trial size 75 participants
Trial identifier NCT00932854, REMEDY 09/0090

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
ebus EBUS-TBNA
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 Outcomes

Measure
Number of mediastinoscopies prevented and healthcare costs
time frame: At diagnosis

Secondary Outcomes

Measure
Length of hospital stay
time frame: At diagnosis
Sensitivity and false negative rate of endobronchial ultrasound
time frame: At study completion

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of Isolated MEDiastinal lymphadenopathY (REMEDY)
Principal investigator Sam Janes, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by University College London Hospitals.