Clinical trial NCT01383226: Linear Endosonography for the Assessment of Sarcoidosis Stage O
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphadenitis
Keywords: endosonography
enlarged thoracic lymph adenopathies
non-cancer patient
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic sensitivity
timeFrame: One year
Secondary outcomes:
measure: Clinical impact.
timeFrame: One year
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Middelheim Ziekenhuis
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brussels
country: Belgium
facility: Hopital Saint-Pierre Bruxelles
city: Charleroi
country: Belgium
facility: Centre Hospitalier Universitaire Charleroi
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Roeselare
country: Belgium
facility: Heilig Hart Ziekenhuis Roeselare
city: Turnhout
country: Belgium
facility: Sint-Elisabeth Ziekenhuis
city: Woluwe
country: Belgium
facility: Université Catholic Louvain
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Christophe A Dooms, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Saint-Pierre Brussels
name: Vincent Ninane, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: