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
18 Years
N/A
Both
Lymphadenitis
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Diagnostic sensitivity
Outcome 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.
Outcome Time Frame:
One year
Safety Issue:
No
Principal Investigator
Christophe A Dooms, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospitals Leuven
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
S53313
NCT ID:
NCT01383226
Start Date:
June 2011
Completion Date:
September 2012
Related Keywords:
- Lymphadenitis
- endosonography
- enlarged thoracic lymph adenopathies
- non-cancer patient
- Lymphadenitis
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