Linear Endosonography for the Assessment of Sarcoidosis Stage O

NCT01383226 | Completed

• 1 other identifier: S53313
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Lymphadenitis

Keywords

endosonography; enlarged thoracic lymph adenopathies; non-cancer patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical impact.

  One year

Study Arms (1)

Thoracic endosonography

OTHER

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

Procedure: Thoracic endosonography

Interventions

Thoracic endosonography PROCEDURE

Thoracic endosonography is a minimal invasive diagnostic intervention

Thoracic endosonography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (9)

Middelheim Ziekenhuis

Antwerp, Belgium

Location

Imelda Ziekenhuis

Bonheiden, Belgium

Location

Hopital Saint-Pierre Bruxelles

Brussels, Belgium

Location

Centre Hospitalier Universitaire Charleroi

Charleroi, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Heilig Hart Ziekenhuis Roeselare

Roeselare, Belgium

Location

Sint-Elisabeth Ziekenhuis

Turnhout, Belgium

Location

Université Catholic Louvain

Woluwe, Belgium

Location

MeSH Terms

Conditions

Lymphadenitis

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Christophe A Dooms, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Vincent Ninane, MD, PhD

  Hopital Saint-Pierre Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

BE (9)