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Clinical Effectiveness of a Balloon Covered Sheath as a Guide Sheath in Endobronchial Ultrasound Guided Diagnosis of Peripheral Lung Lesions

18 Years
Not Enrolling
Pulmonary Neoplasms, Solitary Pulmonary Nodules

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Trial Information

Clinical Effectiveness of a Balloon Covered Sheath as a Guide Sheath in Endobronchial Ultrasound Guided Diagnosis of Peripheral Lung Lesions

Flexible bronchoscopy has been applied in the diagnosis of peripheral pulmonary lesions
(PPLs) for decades. Without accurate localization, the diagnostic yield for peripheral lung
cancers by these procedures is limited and variable. Localization of peripheral lung cancers
can be aided by the use of computed tomography or fluoroscopy during fiberoptic
bronchoscopy. However, radiation exposure to staffs and patients is always a concern in
these procedures.

The clinical application of endobronchial ultrasound (EBUS) included determination of the
depth of tumor invasion in tracheobronchial wall, evaluation of tracheobronchial structure
before therapeutic bronchoscopy, localization of site of biopsy, EBUS-guided transbronchial
needle aspiration, and analysis of peripheral tumor. Under EBUS guidance, the diagnostic
yield of transbronchial lung biopsy in patients with peripheral lung cancer by bronchoscopic
examination was significantly improved without an increase in the complication rate. More
recently, with the aid of a guide sheath (EBUS-GS), EBUS has been shown to increase the
diagnostic yield of PPLs, even in patients with fluoroscopy-invisible lung nodules, and
avert the need for surgical procedures.

Most recently used GS for EBUS are specified for the EBUS probe with an external diameter of
1.9 mm. Such a thin caliber GS is designed to reach the PPLs, sometimes with an aid of
curette, to provide an exact site for repeated obtainment of adequate specimens. We wonder
whether a larger caliber sheath transformed from a balloon covered with an external diameter
of 2.6 mm without reaching the PPLs, can offer similar effectiveness in diagnosis of the
PPLs. The results may provide an alternative way for EBUS-GS especially in those countries
where the commonly used GS of EBUS is not available.

Inclusion Criteria:

- patients with peripheral pulmonary lesions who are going to receive bronchoscopy

Exclusion Criteria:

- endobronchial abnormalities

- associated lung parenchyma changes, ex. lung collapse or atelectasis

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

the diagnostic efficiency of flexible bronchoscopy(FB) in peripheral lung lesions(PPLs)

Outcome Time Frame:

1 year

Safety Issue:



Taiwan: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

March 2009

Related Keywords:

  • Pulmonary Neoplasms
  • Solitary Pulmonary Nodules
  • endobronchial ultrasound
  • guide sheath
  • peripheral pulmonary lesions
  • Neoplasms
  • Lung Neoplasms
  • Solitary Pulmonary Nodule