Brief Summary

The development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal lymph node (MLN) sampling. Still, in some diseases routine cytological specimens are considered insufficient and histological sampling is preferred. The aim of the study is to compare the diagnostic accuracy of EBUS-TBNA and two other, more invasive procedures to obtain histological samples from MLN in patients with clinical and radiological features of sarcoidosis. Bronchoscopy with bronchoalveolar lavage (BAL), EBUS-TBNA, EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histology TBNA as well as endobronchial forceps biopsy will be performed in 90 consecutive patients with mediastinal lymph node enlargement and clinical and radiological features of sarcoidosis. Diagnostic accuracy of each sampling technique will be calculated and compared to other techniques. Diagnostic yield of different technique combinations will also be calculated and the most efficient diagnostic approach will be defined.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Mar 2013

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

March 1, 2013

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed

Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

April 17, 2013

Last Update Submit

February 11, 2014

Conditions

Mediastinal Lymph Node Enlargement Sarcoidosis Tuberculosis Lymphomas

Keywords

mediastinal lymph node enlargementsarcoidosisbronchoscopyEBUS guided transbronchial needle aspiration (EBUS-TBNA)transbronchial needle aspiration (EBUS-TBNA)EBUS guided transbronchial forceps biopsy EBUS-TBFB)

Outcome Measures

Primary Outcomes (1)

Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.
Comparison of the diagnostic yield of the cytologic and histologic specimens collected by EBUS-TBNA, EBUS-TBFB, large bore TBNA, endobronchial forceps biopsy and BAL in terms of making the diagnosis of sarcoidosis.
Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available

Secondary Outcomes (1)

Adequacy of cytologic and histopathologic specimens collected by different sampling method as the diagnostic samples enabling confirmation of granulomatous lymph node disease.
up to 9 months

Other Outcomes (1)

Local complications of mediastinal lymph node sampling
During and 24 hrs after bronchoscopic procedure

Study Arms (1)

Bronchoscopic lymph node sampling

EXPERIMENTAL

Several different sampling techniques will be used in each patient. They include: EBUS guided transbronchial needle aspiration (EBUS-TBNA), EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histologic needle biopsy of the mediastinal lymph nodes, forceps biopsy of bronchial mucosa in central and peripheral bronchi

Procedure: EBUS guided transbronchial forceps biopsy (EBUS-TBFB)Procedure: EBUS guided transbronchial needle aspiration (EBUS-TBNA)Procedure: large bore (19G) histologic needle biopsy of the mediastinal lymph nodesProcedure: Bronchoalveolar lavage (BAL)Procedure: Endobronchial forceps biopsy