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

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Pulmonary Neoplasms Solitary Pulmonary Nodules Device: guide sheath Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Effectiveness of a Balloon Covered Sheath as a Guide Sheath in Endobronchial Ultrasound Guided Diagnosis of Peripheral Lung Lesions
Study Start Date : April 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. the diagnostic efficiency of flexible bronchoscopy(FB) in peripheral lung lesions(PPLs) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. complications, including bleeding, pneumothorax, respiratory failure, [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00922155

Department or Chest Medicine, Chang Gung Memorial Hospital
Taipei, Taiwan, 10507
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan

Responsible Party: Yung-Lun Ni, Chang Gung Memorial Hospital Identifier: NCT00922155     History of Changes
Other Study ID Numbers: 96-0011B
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: March 2007

Keywords provided by Chang Gung Memorial Hospital:
endobronchial ultrasound
guide sheath
peripheral pulmonary lesions

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases