1. Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a14% higher granuloma detection rate compared to endobronchial ultrasound (EBUS)guided nodal sampling in patients with suspected sarcoidosis stage I/II.2. 25G ProCore…
ID
Source
Brief title
Condition
- Thoracic disorders (excl lung and pleura)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Sensitivity of EBUS-TBNA for diagnosing sarcoidosis;
Sensitivity of EUS-B-FNA for diagnosing sarcoidosis;
Granuloma detection rate of the conventional 22G needle and 25G ProCore neelde;
Complications;
Background summary
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 beleved ProCore needle, allows tissue
acquisition
of small core biopsies in addition to cytological aspirates.
Study objective
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.
With the results of this study we expect to improve the diagnosis of
sarcoidosis.
Study design
Investigator initiated, randomized clinical trial.
Setting: International, multicenter (university and general hospitals)
Intervention: EBUS vs EUS-B, simultaneously comparing the standard vs novel
ProCore needles.
Study burden and risks
Patients have an indication for endosonography. In case of study participation
patients wil be randomized for EBUS or EUS-B. In case patients decline study
participation the treating physician decides the route (EBUS or EUS-B).
meibergdreef 9
amsterdam 1105 AZ
NL
meibergdreef 9
amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Clinical and radiologic suspicion of sarcoidose stage I (mediastinal or hilar lymphadenopathy) or stage II (lymphadenopathy and interparenchymal abnormalities);
Indication for tissue verification of noncaseating granuloma*s;
Exclusion criteria
Life expectancy 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;
Under 18 years of age;
Pregnancy;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51598.018.15 |