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

Primary Purpose

Lung Cancer, Sarcoidosis, Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rapid on-site cytopathologic evaluation (ROSE)
TBNA
Sponsored by
Maggiore Bellaria Hospital, Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Transbronchial needle aspiration, Bronchoscopy, Rapid on-site cytopathologic evaluation, Mediastinal lymphadenopathy, Hilar Lymphadenopathy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maggiore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TBNA alone

TBNA with ROSE

Arm Description

Arm A: TBNA alone.

Arm B: TBNA with ROSE.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm
Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm
Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm

Full Information

First Posted
June 4, 2009
Last Updated
February 18, 2010
Sponsor
Maggiore Bellaria Hospital, Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT00915330
Brief Title
Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maggiore Bellaria Hospital, Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Sarcoidosis, Tuberculosis
Keywords
Transbronchial needle aspiration, Bronchoscopy, Rapid on-site cytopathologic evaluation, Mediastinal lymphadenopathy, Hilar Lymphadenopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (false)

8. Arms, Groups, and Interventions

Arm Title
TBNA alone
Arm Type
Active Comparator
Arm Description
Arm A: TBNA alone.
Arm Title
TBNA with ROSE
Arm Type
Experimental
Arm Description
Arm B: TBNA with ROSE.
Intervention Type
Procedure
Intervention Name(s)
Rapid on-site cytopathologic evaluation (ROSE)
Intervention Description
ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.
Intervention Type
Procedure
Intervention Name(s)
TBNA
Intervention Description
transbronchial needle aspiration
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm
Time Frame
6-12 months
Title
Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm
Time Frame
6-12 months
Title
Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Patelli, MD
Organizational Affiliation
Maggiore Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maggiore Hospital
City
Bologna
ZIP/Postal Code
40133
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15824529
Citation
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. doi: 10.1159/000084050.
Results Reference
result
PubMed Identifier
2361413
Citation
Davenport RD. Rapid on-site evaluation of transbronchial aspirates. Chest. 1990 Jul;98(1):59-61. doi: 10.1378/chest.98.1.59.
Results Reference
result
PubMed Identifier
16100180
Citation
Baram D, Garcia RB, Richman PS. Impact of rapid on-site cytologic evaluation during transbronchial needle aspiration. Chest. 2005 Aug;128(2):869-75. doi: 10.1378/chest.128.2.869.
Results Reference
result
PubMed Identifier
10767258
Citation
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. doi: 10.1378/chest.117.4.1186.
Results Reference
result
PubMed Identifier
21030491
Citation
Trisolini R, Cancellieri A, Tinelli C, Paioli D, Scudeller L, Casadei GP, Forti Parri S, Livi V, Bondi A, Boaron M, Patelli M. Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial. Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28.
Results Reference
derived

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

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