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

NCT ID: NCT00626587

Last Updated: 2008-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Peripheral Pulmonary Lesions

Keywords

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Endobronchial ultrasonography Peripheral pulmonary lesions Transbronchial needle aspiration Probe location Diagnostic yield EBUS guided TBNA for peripheral pulmonary lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Conventional diagnostic procedures (transbronchial biopsy and bronchial washing) for peripheral pulmonary lesions

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Patients with peripheral pulmonary lesions (PPLs)

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Internal Medicine, Chang Gung Memorial Hospital

Principal Investigators

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Lin Meng-Chih, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital-Kaohsiung Medical Center

Locations

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Chang Gung Memorial Hospital-Kaohsiung Medical Center

Niaosung Shiang, Kaohsiung, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 18812446 (View on PubMed)

Other Identifiers

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96-0861B

Identifier Type: -

Identifier Source: secondary_id

CGMH-94-0101A

Identifier Type: -

Identifier Source: org_study_id