Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

Lung Cancer Clinical Trial

Official title:

Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Using Peripheral Endobronchial Ultrasonography and Electromagnetic Navigation Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925210
• Other study ID #: 22176
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2009
• Last updated: September 10, 2010
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule

Intervention

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.

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic yield			No
Secondary	sensitivity, specificity, positive and negative predictive value			No
Secondary	Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield			No
Secondary	Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared			No
Secondary	Complication rate			Yes

External Links

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