Clinical trial NCT02540694: EBUS vs EUS-B for Diagnosing Sarcoidosis
Official title: Endobronchial vs. Esophageal Ultrasound for Diagnosing Sarcoidosis: A Randomized Clinical Trial; - A Standard vs. - ProCore Needle Comparison -
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcoidosis
Endosonography
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Cook Medical
First posted: 2015-09-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 weeks after the endosonography procedure.
measure: Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.
timeFrame: 9 months after inclusion of last patient.
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jouke T Annema, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crombag LMM, Mooij-Kalverda K, Szlubowski A, Gnass M, Tournoy KG, Sun J, Oki M, Ninaber MK, Steinfort DP, Jennings BR, Liberman M, Bilaceroglu S, Bonta PI, Korevaar DA, Trisolini R, Annema JT. EBUS versus EUS-B for diagnosing sarcoidosis: The International Sarcoidosis Assessment (ISA) randomized clinical trial. Respirology. 2022 Feb;27(2):152-160. doi: 10.1111/resp.14182. Epub 2021 Nov 17.