EBUS vs EUS-B for Diagnosing Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Endobronchial vs. Esophageal Ultrasound for Diagnosing Sarcoidosis: A Randomized Clinical Trial; - A Standard vs. - ProCore Needle Comparison -

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02540694
• Other study ID #: NL51598.018.15
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2015
• Last updated: September 3, 2015
• Start date: May 2015
• Est. completion date: June 2018

Study information

• Verified date: September 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Laurence MM Crombag, MD
• Phone: 31205664356
• Email: l.m.crombag[@]amc.nl
• Is FDA regulated: No
• Health authority: The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endosonography
• Sarcoidosis

Intervention

Device:
• Endosonography

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Cook Medical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.	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).	9 months after inclusion of last patient.	No