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

This study has been completed.
Sponsor:
Information provided by:
Maggiore Bellaria Hospital, Bologna
ClinicalTrials.gov Identifier:
NCT00915330
First received: June 4, 2009
Last updated: February 18, 2010
Last verified: February 2010
  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
Endpoint Classification: Efficacy Study
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: June 4, 2009
Last Updated: February 18, 2010
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Lung Neoplasms
Sarcoidosis
Tuberculosis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 26, 2014