Trial for the Diagnosis of Sarcoidosis (GRANULOMA)

December 4, 2015 updated by: M.B. von Bartheld, Leiden University Medical Center

Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial

This randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage I/II.

The objective is to assess the role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB).

Also the researchers investigate the additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis.

Thirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sarcoidosis is the most prevalent interstitial lung disease in Western-Europe and the US. The disease is most prevalent in young adults. To set the final diagnosis of sarcoidosis, the following parameters need to be present:

  1. A clinical and radiological suspicion of sarcoidosis stage I/II.
  2. A tissue diagnosis of disease-specific non-caseating granulomas.
  3. Exclusion of possible alternative diagnoses as lung cancer or tuberculosis.

Nowadays, a bronchoscopy with lung biopsies is advised to set a tissue diagnosis of sarcoidosis. However, these biopsies are only diagnostic in 70% of the procedures and they are associated with a 3% risk of coughing up blood and a 4% risk of a lung collapse.

Since recently, a new diagnostic procedure has come available. This procedure, endo-sonography, makes it possible to biopsy lymph nodes in the chest under direct visualization and has a diagnostic accuracy of 85%. The associated risk of complications appears to be small (<1%)

We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography. We expect that endo-sonography is more frequent diagnostic for a tissue diagnosis of sarcoidosis.

Also we hypothesize that this technique is safer and more preferred by patients.

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 3

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

  • Belgium
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
  • Denmark
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, 2900
        • Gentofte Hospital Copenhagen
  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69126
        • Thoraxklinik Heidelberg
    • Schleswig-Holstein
      • Grosshansdorf, Schleswig-Holstein, Germany, 22927
        • Hospital Grosshansdorf
  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands
        • Rijnstaete Ziekenhuis
      • Nijmegen, Gelderland, Netherlands
        • Radboud Universitair Medisch Centrum
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands
        • St. Catharina Ziekenhuis
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands
        • Medisch Centrum Haaglanden
      • Leiden, Zuid-Holland, Netherlands, 2300 RC
        • Pulmonary Department, Leiden University Medical Center
      • Rotterdam, Zuid-Holland, Netherlands, 3015 CE
        • Erasmus Medisch Centrum
      • Rotterdam, Zuid-Holland, Netherlands
        • St. Franciscus ziekenhuis
  • Poland
      • Krakow, Poland
        • University hospital Krakow, J.P. II
      • Zakopane, Poland
        • Sokołowski Pulmonary Hospital
  • United Kingdom
      • London, United Kingdom
        • Royal Brompton Hospital
      • London, United Kingdom, SW10 9NH
        • Chelsea and Westminster 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:

  • Patients with suspected pulmonary sarcoidosis stage I/ II
  • Age > 18 years
  • Both males and females
  • Written informed consent is obtained.

Exclusion Criteria:

  • Patients with obvious other organ involvement of sarcoidosis where a simple diagnostic biopsy to assess granulomas can be performed.
  • Löfgren's syndrome
  • Inability to undergo fiberbronchoscopy, EBUS or EUS (e.g. respiratory insufficiency, esophageal stenosis
  • Contraindications for a lung or nodal biopsy (e.g. coagulopathy, thrombocytopenia)
  • Pregnancy
  • Inability to obtain informed consent

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Endosonography arm
Procedure: EUS-FNA/EBUS-TBNA + BAL

EUS-FNA = Endoscopic Ultrasound guided fine needle aspiration of mediastinal lymph nodes.

EBUS-TBNA = Endobronchial Ultrasound guided transbronchial needle aspiration of mediastinal and hilar lymph nodes.

BAL = bronchoalveolar lavage
Active Comparator: B
Conventional bronchoscopy arm
Procedure: EBB + TBLB + BAL
EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB)
Time Frame: within a week
within a week

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of complications of both the endosonography and conventional bronchoscopic workup
Time Frame: within 30 days
within 30 days
The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis
Time Frame: 2 weeks
2 weeks
Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up.
Time Frame: within a week
within a week

Collaborators and Investigators

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

Sponsor

Leiden University Medical Center

Investigators

  • Study Director: M B von Bartheld, MSc, Pulmonary Department, Leiden University Medical Center
  • Principal Investigator: J T Annema, MD PhD, Pulmonary Department, Leiden University Medical Center
  • Principal Investigator: K F Rabe, MD PhD, Pulmonary Department, Leiden University Medical Center

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

March 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 30, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (Estimate)

March 31, 2009

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUMC-GRANULOMA

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.

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