Linear Endosonography for the Assessment of Sarcoidosis Stage O (LASSO)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Lymphadenitis

Treatments: Procedure: Thoracic endosonography

Study type: Interventional

Funder types: Other

Identifiers

NCT01383226

S53313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Thoracic endosonography

Other group

Description:

Thoracic endosonography, either endobronchial or esophageal ultrasound controlled needle aspiration, is a minimally invasive diagnostic technique.

Treatment:

Procedure: Thoracic endosonography