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Completed

NCT Number: NCT00915330

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

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.

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Key information

Conditions

Lung Cancer Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Infections Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoproliferative Disorders Mycobacterium Infections Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoidosis Thoracic Neoplasms Tuberculosis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maggiore Hospital

Bologna, 40133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid on-site cytopathologic evaluation (ROSE)

Procedure

ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.

TBNA

Procedure

transbronchial needle aspiration

Primary outcomes

  1. Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm

    Time frame: 6-12 months

Secondary outcomes

  1. Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm

    Time frame: 6-12 months

  2. Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm

    Time frame: 6-12 months

  3. Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm

    Time frame: 6-12 months

Sponsors and collaborators

Lead sponsor

Maggiore Bellaria Hospital, Bologna

Other

Registry information

Official study title

Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 8, 2009
Registry last updated
Feb 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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