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| Name | Class |
|---|---|
| Cook Medical | UNKNOWN |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBNA using 22G needle | Active Comparator | EBUS-TBNA using 22G needle (transbronchial route) |
|
| EBUS-TBNA using 25G ProCore needle | Active Comparator | EBUS-TBNA using 25G ProCore needle (transbronchial route) |
|
| EUS-B-FNA using 22G needle | Active Comparator | EUS-B-FNA using 22G needle (transoesophageal route) |
|
| EUS-B-FNA using 25G ProCOre needle | Active Comparator | EUS-B-FNA using 25G ProCOre needle (transoesophageal route) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endosonography | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurence MM Crombag, MD | Contact | 31205664356 | l.m.crombag@amc.nl | |
| Jouke T Annema, Prof | Contact | 31205664356 | j.t.annema@amc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jouke T Annema, Prof | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Recruiting | Amsterdam | Amsterdam | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34792268 | Derived | 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. |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| ID | Term |
|---|---|
| D019160 | Endosonography |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |