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

October 17, 2011 updated by: Sam Janes, University College London Hospitals

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E 5DB
        • University College London Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of mediastinoscopies prevented and healthcare costs
Time Frame: At diagnosis
At diagnosis

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: At diagnosis
At diagnosis
Sensitivity and false negative rate of endobronchial ultrasound
Time Frame: At study completion
At study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College London Hospitals

Investigators

  • Principal Investigator: Sam Janes, MD PhD, University College, London
  • Study Director: Neal Navani, MD, Univeristy College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

July 2, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Estimate)

October 18, 2011

Last Update Submitted That Met QC Criteria

October 17, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REMEDY 09/0090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe