Trial for the Diagnosis of Sarcoidosis (GRANULOMA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Leiden University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
M.B. von Bartheld, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00872612
First received: March 30, 2009
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Sarcoidosis
Procedure: EUS-FNA/EBUS-TBNA + BAL
Procedure: EBB + TBLB + BAL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB) [ Time Frame: within a week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of complications of both the endosonography and conventional bronchoscopic workup [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
  • The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up. [ Time Frame: within a week ] [ Designated as safety issue: No ]

Enrollment: 304
Study Start Date: March 2009
Estimated Study Completion Date: May 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872612

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.B. von Bartheld, MB von Bartheld, MSc. PhD Student, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00872612     History of Changes
Other Study ID Numbers: LUMC-GRANULOMA
Study First Received: March 30, 2009
Last Updated: January 3, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
Sarcoidosis
Diagnosis
Non-caseating granulomas
BAL
EUS-FNA
EBUS-TBNA
TBLB

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014