Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT00925210

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Solitary Pulmonary Nodule Lung Cancer	Procedure: Sequential pEBUS - ENB	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequential pEBUS - ENB	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.

Arm

Intervention/Treatment

Experimental: Sequential pEBUS - ENB

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.

Outcome Measures

Primary Outcome Measures

diagnostic yield []

Secondary Outcome Measures

sensitivity, specificity, positive and negative predictive value []
Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield []
Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared []
Complication rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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