Linear Endosonography for the Assessment of Sarcoidosis Stage O

Not Applicable

Completed

• Conditions: Lymphadenitis
• Interventions: Procedure: Thoracic endosonography

• Registration Number: NCT01383226
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2013-10
• Study Completion: 2014-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Diagnostic sensitivity	One year	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.

Secondary Outcome Measures

Name	Time	Method
Clinical impact.	One year	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 Locations

Locations (9)

Ghent University Hospital; 🇧🇪 Ghent, Belgium

Centre Hospitalier Universitaire Charleroi; 🇧🇪 Charleroi, Belgium

Middelheim Ziekenhuis; 🇧🇪 Antwerpen, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

Hopital Saint-Pierre Bruxelles; 🇧🇪 Brussels, Belgium

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Heilig Hart Ziekenhuis Roeselare; 🇧🇪 Roeselare, Belgium

Sint-Elisabeth Ziekenhuis; 🇧🇪 Turnhout, Belgium

Université Catholic Louvain; 🇧🇪 Woluwe, Belgium