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

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ClinicalTrials.gov Identifier: NCT00915330
Recruitment Status : Completed
First Posted : June 8, 2009
Last Update Posted : February 19, 2010
Sponsor:
Information provided by:
Maggiore Bellaria Hospital, Bologna

Tracking Information
First Submitted Date  ICMJE June 4, 2009
First Posted Date  ICMJE June 8, 2009
Last Update Posted Date February 19, 2010
Study Start Date  ICMJE May 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm [ Time Frame: 6-12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy
Official Title  ICMJE Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Lung Cancer
  • Sarcoidosis
  • Tuberculosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: TBNA alone
    Arm A: TBNA alone.
    Intervention: Procedure: TBNA
  • Experimental: TBNA with ROSE
    Arm B: TBNA with ROSE.
    Interventions:
    • Procedure: Rapid on-site cytopathologic evaluation (ROSE)
    • Procedure: TBNA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 5, 2009)
164
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00915330
Other Study ID Numbers  ICMJE 01-Trisolini
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marco Patelli, Maggiore Bellaria Hospital
Study Sponsor  ICMJE Maggiore Bellaria Hospital, Bologna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marco Patelli, MD Maggiore Hospital
PRS Account Maggiore Bellaria Hospital, Bologna
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP