Clinical trial NCT00626587: EBUS-Guided TBNA Increases the Diagnostic Yield of Peripheral Pulmonary Lesions
Official title: Endobronchial Ultrasonography-Guided Transbronchial Needle Aspiration Increases the Diagnostic Yield of Peripheral Pulmonary Lesions : A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Pulmonary Lesions
Keywords: Endobronchial ultrasonography
Peripheral pulmonary lesions
Transbronchial needle aspiration
Probe location
Diagnostic yield
EBUS guided TBNA for peripheral pulmonary lesions
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 182
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Patients with peripheral pulmonary lesions (PPLs)

Exclusion Criteria:

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

Primary outcomes:
measure: The diagnostic yield of EBUS-guided TBNA in PPLs
timeFrame: Follow up of final diagnosis
Secondary outcomes:
measure: The role of TBNA when EBUS probe was adjacent to the lesions
timeFrame: Follow up of diagnosis
Other outcomes:
Locations:
city: Niaosung Shiang
country: Taiwan
facility: Chang Gung Memorial Hospital-Kaohsiung Medical Center
state: Kaohsiung
Study officials:
affiliation: Chang Gung Memorial Hospital-Kaohsiung Medical Center
name: Lin Meng-Chih, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chao TY, Chien MT, Lie CH, Chung YH, Wang JL, Lin MC. Endobronchial ultrasonography-guided transbronchial needle aspiration increases the diagnostic yield of peripheral pulmonary lesions: a randomized trial. Chest. 2009 Jul;136(1):229-236. doi: 10.1378/chest.08-0577. Epub 2008 Sep 23.