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

Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915330
• Other study ID #: 01-Trisolini
• Status: Completed
• Phase: N/A
• First received: June 4, 2009
• Last updated: February 18, 2010
• Start date: May 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Maggiore Bellaria Hospital, Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Sarcoidosis
• Tuberculosis

Intervention

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.
• TBNA
transbronchial needle aspiration

Locations

Country	Name	City	State
Italy	Maggiore Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Maggiore Bellaria Hospital, Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm		6-12 months	No
Secondary	Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm		6-12 months	No
Secondary	Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm		6-12 months	No
Secondary	Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm		6-12 months	No