Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

NCT00925210 | Completed Phase 2

• 1 other identifier: 22176
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Solitary Pulmonary Nodule; Lung Cancer

Keywords

Endobronchial ultrasound; Electromagnetic Navigation Bronchoscopy; Bronchoscopy; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• diagnostic yield

Secondary Outcomes (4)

• 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

Study Arms (1)

Sequential pEBUS - ENB

EXPERIMENTAL

Procedure: Sequential pEBUS - ENB

Interventions

Sequential pEBUS - ENB PROCEDURE

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.

Sequential pEBUS - ENB

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

Foothills Medical Center

Calgary, Alberta, T2N4N1, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, G1V4G5, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 22, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

CA (2)