EBUS vs EUS-B for Diagnosing Sarcoidosis
Endobronchial vs. Esophageal Ultrasound for Diagnosing Sarcoidosis: A Randomized Clinical Trial; - A Standard vs. - ProCore Needle Comparison -
1 other identifier
interventional
350
1 country
1
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.
- 3.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.
- 4.Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedSeptember 4, 2015
September 1, 2015
2.5 years
August 31, 2015
September 3, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (4)
EBUS-TBNA using 22G needle
ACTIVE COMPARATOREBUS-TBNA using 22G needle (transbronchial route)
EBUS-TBNA using 25G ProCore needle
ACTIVE COMPARATOREBUS-TBNA using 25G ProCore needle (transbronchial route)
EUS-B-FNA using 22G needle
ACTIVE COMPARATOREUS-B-FNA using 22G needle (transoesophageal route)
EUS-B-FNA using 25G ProCOre needle
ACTIVE COMPARATOREUS-B-FNA using 25G ProCOre needle (transoesophageal route)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Medical Center
Amsterdam, Amsterdam, 1105 AZ, Netherlands
Related Publications (1)
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.
PMID: 34792268DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jouke T Annema, Prof
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 4, 2015
Study Start
May 1, 2015
Primary Completion
November 1, 2017
Study Completion
June 1, 2018
Last Updated
September 4, 2015
Record last verified: 2015-09