Clinical trial NCT00922155: Diagnosis of Lung Lesions by Endobronchial Ultrasound With an Alternative Guide Sheath
Official title: Clinical Effectiveness of a Balloon Covered Sheath as a Guide Sheath in Endobronchial Ultrasound Guided Diagnosis of Peripheral Lung Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Neoplasms
Solitary Pulmonary Nodules
Keywords: endobronchial ultrasound
guide sheath
peripheral pulmonary lesions
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2009-06-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: the diagnostic efficiency of flexible bronchoscopy(FB) in peripheral lung lesions(PPLs)
timeFrame: 1 year
Secondary outcomes:
measure: complications, including bleeding, pneumothorax, respiratory failure,
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department or Chest Medicine, Chang Gung Memorial Hospital
Study officials:
References: