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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01383226
First received: June 24, 2011
Last updated: October 8, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention
Lymphadenitis
Procedure: Thoracic endosonography

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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Diagnostic sensitivity [ Time Frame: One year ] [ Designated as safety issue: No ]
    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:
  • Clinical impact. [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383226

Locations
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, 9000
University Hospitals Leuven
Leuven, Belgium, 3000
Heilig Hart Ziekenhuis Roeselare
Roeselare, Belgium
Sint-Elisabeth Ziekenhuis
Turnhout, Belgium
Université Catholic Louvain
Woluwe, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Christophe A Dooms, MD, PhD University Hospitals Leuven
Principal Investigator: Vincent Ninane, MD, PhD Hopital Saint-Pierre Brussels
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01383226     History of Changes
Other Study ID Numbers: S53313
Study First Received: June 24, 2011
Last Updated: October 8, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
endosonography
enlarged thoracic lymph adenopathies
non-cancer patient

Additional relevant MeSH terms:
Lymphadenitis
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014