NCT01456741

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
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
PROCEDURE	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

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-10-21
• Last updated: 2014-05-20

Locations

1 site across 1 country: Italy