Clinical trial NCT01456741: The Role of Endobronchial Needle Aspiration With Rapid On-site Evaluation in the Diagnosis of Central Malignant Lesions
Official title: Endobronchial Needle Aspiration With Rapid On-Site Evaluation in the Diagnosis of Central Malignant Lesions, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: endobronchial needle aspiration (EBNA)
transbronchial needle aspiration (TBNA)
rapid on-site evaluation (ROSE)
lung cancer
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: the sensitivity of the technique of endobronchial needle aspiration with rapid on-site evaluation for the diagnosis of endobronchial lung cancer
timeFrame: 10 day
measure: 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
timeFrame: 10 days
Secondary outcomes:
measure: the impact of rapid on-site evaluation on number of passes during endobronchial needle aspiration
timeFrame: 30 min
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano
Study officials:
affiliation: Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
name: Michele Mondoni, MD
role: STUDY_DIRECTOR
affiliation: Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
name: Paolo Carlucci, MD
role: STUDY_CHAIR
affiliation: Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
name: Stefano Centanni, MD
role: PRINCIPAL_INVESTIGATOR
References: