Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

NCT ID: NCT00925210

Last Updated: 2010-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sequential pEBUS - ENB

Group Type: EXPERIMENTAL

Sequential pEBUS - ENB

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

University of Calgary

Locations

Foothills Medical Center

Calgary, Alberta, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, Canada

Countries

Canada

Related Links

http://www.ucalgary.ca/ipm/

Related Info

Other Identifiers

22176

Identifier Type: -

Identifier Source: org_study_id