Diagnosis of Lung Lesions by Endobronchial Ultrasound With an Alternative

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00922155
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact
Status	Completed
Phase	N/A
Start date	April 2007
Completion date	March 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms