This trial is active, not recruiting.

Condition lymphadenitis
Treatment thoracic endosonography
Sponsor Universitaire Ziekenhuizen Leuven
Start date June 2011
End date October 2013
Trial size 100 participants
Trial identifier NCT01383226, S53313


Patients are often referred for E(B)US examination and sampling of enlarged mediastinal and/or hilar lymph nodes that are not visible on a standard chest X-ray but are discovered by accident on CT scan performed outside the context of lung cancer or extrathoracic malignancies. Since CT scan is largely used and E(B)US is a minimally invasive technique, these cases are explored more frequently but so far nothing is known, however, on the prevalence of abnormal findings in EBUS sampling in this particular population and on the clinical implications (mainly therapeutical implications) of E(B)US findings.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Thoracic endosonography, either endobronchial or esophageal ultrasound controlled needle aspiration, is a minimally invasive diagnostic technique.
thoracic endosonography
Thoracic endosonography is a minimal invasive diagnostic intervention

Primary Outcomes

Diagnostic sensitivity
time frame: One year

Secondary Outcomes

Clinical impact.
time frame: One year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient referred to bronchoscopy for tissue diagnosis of discrete enlarged (≥10mm short axis diameter) mediastinal/hilar lymph nodes on CT scan that can be sampled by E(B)US-NA. Exclusion Criteria: - Abnormal chest X-ray showing hilar/mediastinal lymph nodes - Patients with suspected lung cancer - Patients with previous malignancy diagnosed and definitely treated less than 5 years previously or, if treated more than five years before but with subsequent evidence of recurrence less than 5 years previously. - Patient with concomitant (suspected or confirmed) bronchopulmonary infection or treated with antibiotics within the 4 previous weeks - Patients with a contraindication for bronchoscopy and tissue sampling

Additional Information

Official title CT Enlarged Mediastinal/Hilar Lymph Nodes Not Visible on Chest X-ray in the Non Cancer Patient : Diagnosis and Clinical Implications Using Endobronchial or Esophageal Ultrasound Controlled Needle Aspiration E(B)US-NA
Principal investigator Christophe A Dooms, MD, PhD
Description The primary aim is to assess the nature and prevalence of abnormal findings in samplings obtained during E(B)US-NA in the non-cancer patient with CT enlarged mediastinal/hilar lymph nodes that are not visible on chest X-ray. As secondary aims, the clinical implications of E(B)US-NA findings will be assessed, in particular the number of cases where a specific treatment is initiated.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.