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

NCT00626587 | Completed DMC

• 2 other identifiers: CGMH-94-0101A96-0861B
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Pulmonary Lesions

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The diagnostic yield of EBUS-guided TBNA in PPLs

  Follow up of final diagnosis

Secondary Outcomes (1)

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

  Follow up of diagnosis

Study Arms (1)

A

PLACEBO COMPARATOR

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

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

Interventions

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.

Also known as: TBNA apparatus (Olympus NA-2C-1) for bronchoscopic sampling

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with peripheral pulmonary lesions (PPLs)

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital-Kaohsiung Medical Center

Niaosung Shiang, Kaohsiung, 833, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 18812446 DERIVED

Study Officials

• Lin Meng-Chih, MD

  Chang Gung Memorial Hospital-Kaohsiung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: January 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: February 29, 2008

Record last verified: 2005-01

Locations

TW (1)