MedTrace Logo

Trial for the Diagnosis of Sarcoidosis

NCT00872612 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2015-12-07

No results posted yet for this study

Summary

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.

Conditions

  • Sarcoidosis

Interventions

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

PROCEDURE

EBB + TBLB + BAL

EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • M B von Bartheld, MSc · Pulmonary Department, Leiden University Medical Center

  • J T Annema, MD PhD · Pulmonary Department, Leiden University Medical Center

  • K F Rabe, MD PhD · Pulmonary Department, Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-11-30
Completion
2012-05-31

Countries

  • Belgium
  • Denmark
  • Germany
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00872612 on ClinicalTrials.gov