The Role of Endobronchial Needle Aspiration With Rapid On-site Evaluation in the Diagnosis of Central Malignant Lesions

Lung Cancer Clinical Trial

Official title:

Endobronchial Needle Aspiration With Rapid On-Site Evaluation in the Diagnosis of Central Malignant Lesions, a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456741
• Other study ID #: EBNA08091976
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: May 19, 2014
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2014
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Endobronchial lung cancer tend to manifest in three different patterns. It can present as a bulky, exophytic mass lesion, submucosal infiltration or extrinsic compression from peribronchial disease. Bronchoscopy with differents techniques as forceps biopsy, bronchial brushing and bronchial washing is recognized as the gold standard to diagnose central airways lung neoplasms. Some authors suggested that the addition of endobronchial needle aspiration (EBNA) to these conventional diagnostic methods may increase the sensitivity of bronchoscopy in submucosal and peribronchial disease but few prospective trials have been performed and this procedure is still underutilized in many centers. Rapid on-site evaluation (ROSE) showed to improve yield of transbronchial needle aspiration (TBNA) of mediastinal nodes and pulmonary peripheral lesions, reducing the number of inadequate specimens and costs. However, its utility during endobronchial needle aspiration has not been substantiated.

This prospective study has two primary objectives: to compare the sensitivity of ROSE-EBNA with that of the conventional technique and to investigate the diagnostic yield of endobronchial needle aspiration and its contribution to CDM in the evaluation of patients with endobronchial lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• consecutive adult patients with a suspected central lung cancer at a chest CT scan who need a bronchoscopy for diagnostic purposes

Exclusion Criteria:

• presence of uncontrolled coagulopathy, preexisting known malignancies, and the refusal to sign an informed consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• EBNA with ROSE
The patients in this arm will undergo: A) bronchoscopy, endobronchial needle aspiration (EBNA) with a cytologic needle (21 gauge), at least three forceps biopsies, bronchial brushing and bronchial washing in this procedural sequence with rapid on-site evaluation B) if A will be negative transthoracic needle aspiration or surgical biopsy will be performed C) if A and B will be negative follow-up with computed tomography or positron emission tomography and computed tomography
• standard EBNA
The patients in this arm will undergo: A) bronchoscopy, endobronchial needle aspiration (EBNA) with a cytologic needle (21 gauge), at least three forceps biopsies, bronchial brushing and bronchial washing in this procedural sequence. B)if A will be negative transthoracic needle aspiration or surgical biopsy will be performed C) if A and B will be negative follow-up with computed tomography or positron emission tomography and computed tomography

Locations

Country	Name	City	State
Italy	Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the sensitivity of the technique of endobronchial needle aspiration with rapid on-site evaluation for the diagnosis of endobronchial lung cancer	to determinate the sensitivity of endobronchial needle aspiration with rapid on-site evaluation compared to the conventional technique for the diagnosis of endobronchial lung cancer	10 day	No
Primary	the diagnostic yield of adding endobronchial needle aspiration (with and without rapid on-site evaluation) to conventional diagnostic methods for the diagnosis of endobronchial lung cancer	to investigate the diagnostic yield of adding endobronchial needle aspiration (with and without rapid on-site evaluation) to conventional diagnostic methods versus conventional diagnostic methods (bronchoscopy with forceps biopsies, bronchial brushing and bronchial washing) for the diagnosis of endobronchial lung cancer	10 days	No
Secondary	the impact of rapid on-site evaluation on number of passes during endobronchial needle aspiration	study if the presence of rapid on-site evaluation during endobronchial needle aspiration may reduce the number of passes suggested by literature	30 min	No