EBUS vs EUS-B for Diagnosing Sarcoidosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-06-30

Brief Summary

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Rationale:

Endosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose sarcoidosis stage I and II - in case tissue verification of noncaseating granulomas is indicated. However, the optimal endosonographic approach (endobronchial or transoesophageal) for mediastinal nodal sampling is under discussion.

Secondly, which needle size or type provides optimal tissue sample quality for granuloma detection is unknown. The novel 25 Gauge (G) beveled ProCore needle, allows tissue acquisition of small core biopsies in addition to cytological aspirates.

Hypotheses:

1. Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a 14% higher granuloma detection rate compared to endobronchial ultrasound (EBUS) guided nodal sampling in patients with suspected sarcoidosis stage I/II.
2. 25G ProCore needles provide superior sample quality compared to conventional 22G needles in patients with suspected sarcoidosis stage I/II.

Study design:

Investigator initiated, randomized clinical trial. Setting: International, multicenter (university and general hospitals)

Study population:

Consecutive patients with a clinical and radiologic suspicion of sarcoidosis stage I or II and an indication for tissue verification of non-caseating granulomas are eligible for inclusion.

Intervention:

EBUS vs EUS-B, simultaneously comparing the standard vs novel ProCore needles.

Main study endpoints:

1. The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II.
2. Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.

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Detailed Description

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Conditions

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Sarcoidosis Endosonography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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Endosonography

Intervention Type DEVICE

Other Intervention Names

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EBUS EUS-B

Eligibility Criteria

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Inclusion Criteria

* Clinical and radiologic suspicion of sarcoidosis stage I (mediastinal or hilar lymphadenopathy) or stage II (lymphadenopathy and interparenchymal abnormalities)
* Indication for tissue verification of noncaseating granuloma's
* Provision of a written informed consent

Exclusion Criteria

* Life expectancy of less than 6 months
* Obvious organ involvement of sarcoidosis with the possibility to confirm granulomas with a minimally invasive diagnostic procedure (eg skin lesion or superficial lymph node)
* Positive acid-fast bacilli sputum test
* Contra-indication for endosonography
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No