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Completed

NCT Number: NCT00626587

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

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.

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Key information

Conditions

Peripheral Pulmonary Lesions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital-Kaohsiung Medical Center

Niaosung Shiang, Kaohsiung, 833, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with peripheral pulmonary lesions (PPLs)

Exclusion criteria

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

Treatment and study plan

Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)

Device

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 names: TBNA apparatus (Olympus NA-2C-1) for bronchoscopic sampling

Primary outcomes

  1. The diagnostic yield of EBUS-guided TBNA in PPLs

    Time frame: Follow up of final diagnosis

Secondary outcomes

  1. The role of TBNA when EBUS probe was adjacent to the lesions

    Time frame: Follow up of diagnosis

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Endobronchial Ultrasonography-Guided Transbronchial Needle Aspiration Increases the Diagnostic Yield of Peripheral Pulmonary Lesions : A Randomized Trial

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 29, 2008
Registry last updated
Feb 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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