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Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00915330
First Posted: June 8, 2009
Last Update Posted: February 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maggiore Bellaria Hospital, Bologna
  Purpose
The purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy.

Condition Intervention
Lung Cancer Sarcoidosis Tuberculosis Procedure: Rapid on-site cytopathologic evaluation (ROSE) Procedure: TBNA

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Maggiore Bellaria Hospital, Bologna:

Primary Outcome Measures:
  • Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm [ Time Frame: 6-12 months ]

Secondary Outcome Measures:
  • Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm [ Time Frame: 6-12 months ]
  • Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm [ Time Frame: 6-12 months ]
  • Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm [ Time Frame: 6-12 months ]

Estimated Enrollment: 164
Study Start Date: May 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TBNA alone
Arm A: TBNA alone.
Procedure: TBNA
transbronchial needle aspiration
Experimental: TBNA with ROSE
Arm B: TBNA with ROSE.
Procedure: Rapid on-site cytopathologic evaluation (ROSE)
ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.
Procedure: TBNA
transbronchial needle aspiration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old and older
  • Hilar and/or mediastinal lymphadenopathy (> 1 cm on the short axis, as assessed by contrast-enhanced CT scan (computed tomography))

Exclusion Criteria:

  • Uncontrolled coagulopathy
  • Refusal to sign informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915330


Locations
Italy
Maggiore Hospital
Bologna, Italy, 40133
Sponsors and Collaborators
Maggiore Bellaria Hospital, Bologna
Investigators
Principal Investigator: Marco Patelli, MD Maggiore Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Patelli, Maggiore Bellaria Hospital
ClinicalTrials.gov Identifier: NCT00915330     History of Changes
Other Study ID Numbers: 01-Trisolini
First Submitted: June 4, 2009
First Posted: June 8, 2009
Last Update Posted: February 19, 2010
Last Verified: February 2010

Keywords provided by Maggiore Bellaria Hospital, Bologna:
Transbronchial needle aspiration
Bronchoscopy
Rapid on-site cytopathologic evaluation
Mediastinal lymphadenopathy
Hilar Lymphadenopathy

Additional relevant MeSH terms:
Tuberculosis
Sarcoidosis
Lymphadenopathy
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lymphoproliferative Disorders
Lymphatic Diseases