EBUS-Guided TBNA Increases the Diagnostic Yield of Peripheral Pulmonary Lesions

Not Applicable

Completed

• Conditions: Peripheral Pulmonary Lesions
• Interventions: Device: Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)

• Registration Number: NCT00626587
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The diagnosis of peripheral pulmonary lesions(PPLs) remained a clinical challenge for physicians. Bronchoscope with sampling procedures was recognized as a useful method to obtain the correct diagnosis of PPLs. Conventional diagnostic procedures included transbronchial biopsy(TBB), bronchial washing(BW), or bronchial brushing, but the diagnostic yields were sometimes suboptimal. The diagnostic role of TBNA for PPLs remained to be determined, since many of the published studies were retrospective and had small sample size. This may explain the fact that TBNA was always underutilized for PPLs by bronchologists. With the popular application of EBUS-guided procedures in clinical setting, we performed EBUS-guided TBNA for PPLs. We want to determine whether EBUS-guided TBNA can improve the diagnostic rate of PPLs.

Detailed Description

The diagnostic yield of endobronchial ultrasonography (EBUS)-guided transbronchial needle aspiration (TBNA) for peripheral pulmonary lesions (PPLs) had not been evaluated. The diagnostic impact of TBNA when the EBUS probe was adjacent to lesions remained to be determined.

Here we designed a randomized, prospective study to evaluate : (1) The diagnostic yield of EBUS-guided TBNA in PPLs; (2) The role of TBNA when EBUS probe was adjacent to the lesions. Lesions not visible by bronchoscopy were defined as PPLs (no findings of endobronchial lesions, extrinsic compression, submucosal infiltration, or orifice narrowing). The TBNA apparatus (Olympus NA-2C-1) was inserted through the working channel, and was advanced until it reached the target lesion which was localized by EBUS. Negative manual suction was applied with the 20 ml syringe. The specimens were then smeared on glass slides and immersed in 95% alcohol. At least 3 aspirates per lesion were obtained. Using simple randomization with random digit table, we randomly assigned patients to undergo EBUS-guided TBB and BW or EBUS-guided TBNA, TBB and BW.

Study Timeline

• Status Verified: 2005-01
• Study Start: 2005-01
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2008-02-28
• Last Update Submitted: 2008-02-28
• Study First Posted: 2008-02-29
• Last Update Posted: 2008-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Patients with peripheral pulmonary lesions (PPLs)

Exclusion Criteria

• Repeated bronchoscopic examination
• Positive endobronchial lesions
• Negative EBUS findings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)	Conventional diagnostic procedures (transbronchial biopsy and bronchial washing) for peripheral pulmonary lesions

Primary Outcome Measures

Name	Time	Method
The diagnostic yield of EBUS-guided TBNA in PPLs	Follow up of final diagnosis

Secondary Outcome Measures

Name	Time	Method
The role of TBNA when EBUS probe was adjacent to the lesions	Follow up of diagnosis

Trial Locations

Locations (1)

Chang Gung Memorial Hospital-Kaohsiung Medical Center; 🇨🇳 Niaosung Shiang, Kaohsiung, Taiwan