Diagnosis of Lung Lesions by Endobronchial Ultrasound With an Alternative Guide Sheath

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00922155
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : June 17, 2009
National Science Council, Taiwan
Information provided by:
Chang Gung Memorial Hospital

June 15, 2009
June 17, 2009
June 17, 2009
April 2007
March 2008   (Final data collection date for primary outcome measure)
the diagnostic efficiency of flexible bronchoscopy(FB) in peripheral lung lesions(PPLs) [ Time Frame: 1 year ]
Same as current
No Changes Posted
complications, including bleeding, pneumothorax, respiratory failure, [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
Diagnosis of Lung Lesions by Endobronchial Ultrasound With an Alternative Guide Sheath
Clinical Effectiveness of a Balloon Covered Sheath as a Guide Sheath in Endobronchial Ultrasound Guided Diagnosis of Peripheral Lung Lesions
The purpose of this study is to examine the usefulness of a balloon covered sheath as a guide sheath in endobronchial ultrasound guided transbronchial biopsy and bronchial brushing cytology for 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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Pulmonary Neoplasms
  • Solitary Pulmonary Nodules
Device: guide sheath
The guide sheath (GS) was originally the balloon covered sheath (MAJ-643R, external diameter 2.6mm) of the EBUS probe. The two ends of the balloon covered sheath were cut and trimmed. The EBUS probe was covered with guide sheath and then inserted through the working channel to the targeted bronchus.
  • No Intervention: EBUS
    After the PPLs been localized by endobronchial ultrasound(EBUS), patients in the EBUS group received transbronchial biopsy and bronchial washing at the bronchus located by EBUS.
  • Active Comparator: EBUS-GS
    After PPLs been localized by EBUS, the EBUS and guide sheath were then inserted to localize the lesion again. Transbronchial biopsy and brushing were done through the guide sheath after the probe been removed.
    Intervention: Device: guide sheath
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2009
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Yung-Lun Ni, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
National Science Council, Taiwan
Not Provided
Chang Gung Memorial Hospital
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP