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

Pulmonary Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922155
• Other study ID #: 96-0011B
• Status: Completed
• Phase: N/A
• First received: June 15, 2009
• Last updated: June 15, 2009
• Start date: April 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2007
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Multiple Pulmonary Nodules
• Pulmonary Neoplasms
• Solitary Pulmonary Nodule
• Solitary Pulmonary Nodules

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department or Chest Medicine, Chang Gung Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the diagnostic efficiency of flexible bronchoscopy(FB) in peripheral lung lesions(PPLs)		1 year	Yes
Secondary	complications, including bleeding, pneumothorax, respiratory failure,		1 year	Yes