Linear Endosonography for the Assessment of Sarcoidosis Stage O

Lymphadenitis Clinical Trial

— LASSO  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01383226
• Other study ID #: S53313
• Status: Active, not recruiting
• Phase: N/A
• First received: June 24, 2011
• Last updated: October 8, 2013
• Start date: June 2011
• Est. completion date: April 2014

Study information

• Verified date: June 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphadenitis

Intervention

Procedure:
• Thoracic endosonography
Thoracic endosonography is a minimal invasive diagnostic intervention

Locations

Country	Name	City	State
Belgium	Middelheim Ziekenhuis	Antwerpen
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	Hopital Saint-Pierre Bruxelles	Brussels
Belgium	Centre Hospitalier Universitaire Charleroi	Charleroi
Belgium	Ghent University Hospital	Ghent
Belgium	University Hospitals Leuven	Leuven
Belgium	Heilig Hart Ziekenhuis Roeselare	Roeselare
Belgium	Sint-Elisabeth Ziekenhuis	Turnhout
Belgium	Université Catholic Louvain	Woluwe

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic sensitivity	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.	One year	No
Secondary	Clinical impact.	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.	One year	No