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

Chang Gung Medical Foundation

Status: Completed

Conditions: Pulmonary Neoplasms; Solitary Pulmonary Nodules

Treatments: Device: guide sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT00922155

96-0011B

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

EBUS

No Intervention group

Description:

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.

EBUS-GS

Active Comparator group

Description:

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.

Treatment:

Device: guide sheath