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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphadenitis
• Intervention / Treatment: Procedure: Thoracic endosonography

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Middelheim Ziekenhuis
  • Bonheiden, Belgium
    • Imelda Ziekenhuis
  • Brussels, Belgium
    • Hopital Saint-Pierre Bruxelles
  • Charleroi, Belgium
    • Centre Hospitalier Universitaire Charleroi
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Leuven, Belgium, 3000
    • University Hospitals Leuven
  • Roeselare, Belgium
    • Heilig Hart Ziekenhuis Roeselare
  • Turnhout, Belgium
    • Sint-Elisabeth Ziekenhuis
  • Woluwe, Belgium
    • Université Catholic Louvain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Thoracic endosonography; Thoracic endosonography, either endobronchial or esophageal ultrasound controlled needle aspiration, is a minimally invasive diagnostic technique.	Procedure: Thoracic endosonography; Thoracic endosonography is a minimal invasive diagnostic intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Christophe A Dooms, MD, PhD, Universitaire Ziekenhuizen KU Leuven; Principal Investigator: Vincent Ninane, MD, PhD, Hopital Saint-Pierre Brussels

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 24, 2011
• First Submitted That Met QC Criteria: June 27, 2011
• First Posted (Estimated): June 28, 2011

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: endosonography; enlarged thoracic lymph adenopathies; non-cancer patient
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenitis
• Other Study ID Numbers: S53313