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Clinical Trials/NCT00922155
NCT00922155
Completed
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country180 target enrollmentApril 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Neoplasms
Sponsor
Chang Gung Memorial Hospital
Enrollment
180
Locations
1
Primary Endpoint
the diagnostic efficiency of flexible bronchoscopy(FB) in peripheral lung lesions(PPLs)
Status
Completed
Last Updated
16 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
April 2007
End Date
March 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 1 year

Secondary Outcomes

  • complications, including bleeding, pneumothorax, respiratory failure,(1 year)

Study Sites (1)

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