Rapid on-Site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy - Full Text View

Sponsored by:	Maggiore Bellaria Hospital, Bologna
Information provided by:	Maggiore Bellaria Hospital, Bologna
ClinicalTrials.gov Identifier:	NCT00915330

Purpose

The purpose of this study is to determine whether rapid on-site cytopathologic evaluation 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:	Diagnostic, Randomized, Open Label, Active Control, Efficacy Study
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:

MedlinePlus related topics: Cancer Lung Cancer Lymphatic Diseases Sarcoidosis Tuberculosis

U.S. FDA Resources

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
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
TBNA alone: Active Comparator Arm A: TBNA alone.	Procedure: TBNA transbronchial needle aspiration
TBNA with ROSE: Experimental 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 ojn the short axis, as assessed by contrast-enhanced CT scan)

Exclusion Criteria:

Uncontrolled coagulopathy
Refusal to sign informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915330

Contacts

Contact: Marco Patelli, MD	0039-051-6478728	marco.patelli@ausl.bologna.it
Contact: Rocco Trisolini, MD	0039-051-6478802	rocco.trisolini@ausl.bologna.it

Locations

Italy
Maggiore Hospital	Recruiting
Bologna, Italy, 40133
Contact: Marco Patelli, MD 0039-051-6478728 marco.patelli@ausl.bologna.it
Contact: Rocco Trisolini, MD 0039-051-6478802 rocco.trisolini@ausl.bologna.it
Principal Investigator: Rocco Trisolini, MD

Sponsors and Collaborators

Maggiore Bellaria Hospital, Bologna

Investigators

Principal Investigator:

Marco Patelli, MD

Maggiore Hospital

More Information

Publications:

Diacon AH, Schuurmans MM, Theron J, Louw M, Wright CA, Brundyn K, Bolliger CT. Utility of rapid on-site evaluation of transbronchial needle aspirates. Respiration. 2005 Mar-Apr;72(2):182-8.

Davenport RD. Rapid on-site evaluation of transbronchial aspirates. Chest. 1990 Jul;98(1):59-61.

Baram D, Garcia RB, Richman PS. Impact of rapid on-site cytologic evaluation during transbronchial needle aspiration. Chest. 2005 Aug;128(2):869-75.

Diette GB, White P Jr, Terry P, Jenckes M, Rosenthal D, Rubin HR. Utility of on-site cytopathology assessment for bronchoscopic evaluation of lung masses and adenopathy. Chest. 2000 Apr;117(4):1186-90.

Responsible Party:	Maggiore Bellaria Hospital ( Marco Patelli )
Study ID Numbers:	01-Trisolini
Study First Received:	June 4, 2009
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00915330 History of Changes
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

Study placed in the following topic categories:

Bacterial Infections
Thoracic Neoplasms
Lymphatic Diseases
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Mycobacterium Infections
Tuberculosis
Sarcoidosis
Lymphoproliferative Disorders

Additional relevant MeSH terms:

Bacterial Infections
Thoracic Neoplasms
Respiratory Tract Neoplasms
Sarcoidosis
Actinomycetales Infections
Lymphatic Diseases
Gram-Positive Bacterial Infections
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Mycobacterium Infections
Tuberculosis
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 03, 2009