EBUS-Guided TBNA Increases the Diagnostic Yield of Peripheral Pulmonary Lesions
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|ClinicalTrials.gov Identifier: NCT00626587|
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : February 29, 2008
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Pulmonary Lesions||Device: Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endobronchial Ultrasonography-Guided Transbronchial Needle Aspiration Increases the Diagnostic Yield of Peripheral Pulmonary Lesions : A Randomized Trial|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
Placebo Comparator: A
Conventional diagnostic procedures (transbronchial biopsy and bronchial washing) for peripheral pulmonary lesions
Device: Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)
The TBNA apparatus (Olympus NA-2C-1) is inserted through the working channel, and is advanced until it reaches the target lesion which is localized by EBUS. Negative manual suction is applied with the 20 ml syringe. The specimens are then smeared on glass slides and immersed in 95% alcohol. At least 3 aspirates per lesion are obtained.
Other Name: TBNA apparatus (Olympus NA-2C-1) for bronchoscopic sampling
- The diagnostic yield of EBUS-guided TBNA in PPLs [ Time Frame: Follow up of final diagnosis ]
- The role of TBNA when EBUS probe was adjacent to the lesions [ Time Frame: Follow up of diagnosis ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626587
|Chang Gung Memorial Hospital-Kaohsiung Medical Center|
|Niaosung Shiang, Kaohsiung, Taiwan, 833|
|Principal Investigator:||Lin Meng-Chih, MD||Chang Gung Memorial Hospital-Kaohsiung Medical Center|