Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

Phase 2

Completed

• Conditions: Solitary Pulmonary Nodule; Lung Cancer
• Interventions: Procedure: Sequential pEBUS - ENB

• Registration Number: NCT00925210
• Lead Sponsor: University of Calgary

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 available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-10
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequential pEBUS - ENB	Sequential pEBUS - ENB	-

Primary Outcome Measures

Name	Time	Method
diagnostic yield

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Institut Universitaire de Cardiologie et de Pneumologie de Quebec; 🇨🇦 Quebec, Canada

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada