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

This study has been completed.
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00626587
First received: February 21, 2008
Last updated: February 28, 2008
Last verified: January 2005
History of Changes
  Purpose

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.


Condition Intervention
Peripheral Pulmonary Lesions
 Device: Olympus NA-2C-1 Transbronchial needle aspiration (TBNA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Endobronchial Ultrasonography-Guided Transbronchial Needle Aspiration Increases the Diagnostic Yield of Peripheral Pulmonary Lesions : A Randomized Trial

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • The diagnostic yield of EBUS-guided TBNA in PPLs [ Time Frame: Follow up of final diagnosis ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The role of TBNA when EBUS probe was adjacent to the lesions [ Time Frame: Follow up of diagnosis ] [ Designated as safety issue: No ]

Enrollment: 182
Study Start Date: January 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with peripheral pulmonary lesions (PPLs)

Exclusion Criteria:

  • Repeated bronchoscopic examination
  • Positive endobronchial lesions
  • Negative EBUS findings
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626587

Locations
Taiwan
Chang Gung Memorial Hospital-Kaohsiung Medical Center
Niaosung Shiang, Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Lin Meng-Chih, MD Chang Gung Memorial Hospital-Kaohsiung Medical Center
  More Information

No publications provided by Chang Gung Memorial Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Meng-Chih Lin, Department of Internal Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00626587     History of Changes
Other Study ID Numbers: CGMH-94-0101A, 96-0861B
Study First Received: February 21, 2008
Last Updated: February 28, 2008
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Endobronchial ultrasonography
Peripheral pulmonary lesions
Transbronchial needle aspiration
 Probe location
Diagnostic yield
EBUS guided TBNA for peripheral pulmonary lesions

ClinicalTrials.gov processed this record on June 18, 2013