Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

This study has been completed.

Sponsor:

Information provided by:

University of Calgary

ClinicalTrials.gov Identifier:

NCT00925210

First received: June 18, 2009

Last updated: September 10, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 18, 2009
Last Updated Date	September 10, 2010
Start Date ^ICMJE	June 2009
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 19, 2009)	diagnostic yield [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00925210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 19, 2009)	sensitivity, specificity, positive and negative predictive value [ Designated as safety issue: No ] Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield [ Designated as safety issue: No ] Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared [ Designated as safety issue: No ] Complication rate [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach
Official Title ^ICMJE	Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Using Peripheral Endobronchial Ultrasonography and Electromagnetic Navigation Bronchoscopy
Brief Summary	Patients presenting with solitary or multiple lung nodules often require tissue confirmation in order to guide further management and determine if the lesion is benign or malignant. Several bronchoscopic techniques have emerged which have significantly improved the diagnostic yield of bronchoscopy in this setting, and in particular the combination of peripheral Endobronchial Ultrasonography (pEBUS) and Electromagnetic Navigation Bronchoscopy (ENB) has resulted in diagnostic yields of nearly 90%. In an attempt to reduce the significant cost of this combined approach, the sequential use of pEBUS followed by the more costly ENB technique only if a lesion is not identified on the ultrasound image could be as accurate. This study aims to determine the diagnostic yield of this sequential approach in patients with lung nodule(s).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Solitary Pulmonary Nodule Lung Cancer
Intervention ^ICMJE	Procedure: Sequential pEBUS - ENB Subject will undergo bronchoscopy with peripheral endobronchial ultrasonography to identify the peripheral lung nodule. If the lesion is identified with pEBUS, samples will be collected. If the lesion is not found by pEBUS, the electromagnetic navigation system will be deployed and directed to the lesion of interest, once again using pEBUS to confirm final location before samples are collected.
Study Arm (s)	Experimental: Sequential pEBUS - ENB Intervention: Procedure: Sequential pEBUS - ENB
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	September 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age >16 years Lung nodule (s) identified on CT scan Clinical decision to obtain tissue biopsy of lung lesion CT guided biopsy not preferred technique (previous negative CT guided biopsy or technically difficult nodule location or perceived high risk of pneumothorax or other complications) Pleural based lesion only if: Inaccessible by CT guided biopsy or previous CT guided biopsy non-diagnostic Exclusion Criteria: Lack of informed consent Nodule less than 1 cm or greater than 6 cm long axis Mediastinal adenopathy >2cm short axis on CT chest Evidence of endobronchial abnormality on chest CT Medical contraindication to bronchoscopy Patients with lesions highly suspicious for lung cancer, potentially resectable with lobar or lesser resection and without significantly increased operative risk factors will not be entered into this study prior to surgical evaluation. Patient with implanted electronic medical device Uncontrolled or irreversible coagulopathy (platelets <100, INR >1.3, use of clopidogrel in the 7 days prior to bronchoscopy) Confirmed or suspected pregnancy
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT00925210
Other Study ID Numbers ^ICMJE	22176
Has Data Monitoring Committee	No
Responsible Party	David R. Stather, University of Calgary
Study Sponsor ^ICMJE	University of Calgary
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Calgary
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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