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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
the diagnostic efficiency of flexible bronchoscopy(FB) in peripheral lung lesions(PPLs)
1 year
Yes
Taiwan: Institutional Review Board
96-0011B
NCT00922155
April 2007
March 2009
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