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

Primary Purpose

Pulmonary Neoplasms, Solitary Pulmonary Nodules

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
guide sheath
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Neoplasms focused on measuring endobronchial ultrasound, guide sheath, peripheral pulmonary lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department or Chest Medicine, Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

EBUS

EBUS-GS

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

complications, including bleeding, pneumothorax, respiratory failure,

Full Information

First Posted
June 15, 2009
Last Updated
June 15, 2009
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00922155
Brief Title
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

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Neoplasms, Solitary Pulmonary Nodules
Keywords
endobronchial ultrasound, guide sheath, peripheral pulmonary lesions

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBUS
Arm Type
No Intervention
Arm 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.
Arm Title
EBUS-GS
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
guide sheath
Intervention Description
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.
Primary Outcome Measure Information:
Title
the diagnostic efficiency of flexible bronchoscopy(FB) in peripheral lung lesions(PPLs)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
complications, including bleeding, pneumothorax, respiratory failure,
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department or Chest Medicine, Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
10507
Country
Taiwan

12. IPD Sharing Statement

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

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