Linear Endosonography for the Assessment of Sarcoidosis Stage O

NCT ID: NCT01383226

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-04-30

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.

Conditions

Lymphadenitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Thoracic endosonography

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

Group Type: OTHER

Thoracic endosonography

Intervention Type: PROCEDURE

Thoracic endosonography is a minimal invasive diagnostic intervention

Interventions

Thoracic endosonography

Thoracic endosonography is a minimal invasive diagnostic intervention

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe A Dooms, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Vincent Ninane, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Saint-Pierre Brussels

Locations

Middelheim Ziekenhuis

Antwerp, , 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, , Belgium

Countries

Belgium

Other Identifiers

S53313

Identifier Type: -

Identifier Source: org_study_id