EBUS vs EUS-B for Diagnosing Sarcoidosis

Not Applicable

• Conditions: Sarcoidosis; Endosonography
• Interventions: Device: Endosonography

• Registration Number: NCT02540694
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-08-31
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-03
• Last Update Submitted: 2015-09-03
• Study First Posted: 2015-09-04
• Last Update Posted: 2015-09-04
• Primary Completion: 2017-11
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
EBUS-TBNA using 22G needle	Endosonography	EBUS-TBNA using 22G needle (transbronchial route)
EBUS-TBNA using 25G ProCore needle	Endosonography	EBUS-TBNA using 25G ProCore needle (transbronchial route)
EUS-B-FNA using 22G needle	Endosonography	EUS-B-FNA using 22G needle (transoesophageal route)
EUS-B-FNA using 25G ProCOre needle	Endosonography	EUS-B-FNA using 25G ProCOre needle (transoesophageal route)

Primary Outcome Measures

Name	Time	Method
Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.	9 months after inclusion of last patient.	The sample quality will be assessed by two independent reference pathologists. The performance of each needle (25 ProCore / standard 22 G) will be scored on five items (the modified Mair score).
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 weeks after the endosonography procedure.

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands