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Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

Primary Purpose

Solitary Pulmonary Nodule, Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Sequential pEBUS - ENB
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Solitary Pulmonary Nodule focused on measuring Endobronchial ultrasound, Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Ultrasonography

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Foothills Medical Center
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sequential pEBUS - ENB

Arm Description

Outcomes

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

Full Information

First Posted
June 18, 2009
Last Updated
September 10, 2010
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT00925210
Brief Title
Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach
Official Title
Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Using Peripheral Endobronchial Ultrasonography and Electromagnetic Navigation Bronchoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Pulmonary Nodule, Lung Cancer
Keywords
Endobronchial ultrasound, Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequential pEBUS - ENB
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Sequential pEBUS - ENB
Intervention Description
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.
Primary Outcome Measure Information:
Title
diagnostic yield
Secondary Outcome Measure Information:
Title
sensitivity, specificity, positive and negative predictive value
Title
Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield
Title
Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared
Title
Complication rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.ucalgary.ca/ipm/
Description
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Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

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