Electromagnetic Navigational Bronchoscopy Vs. Transthoracic Needle Biopsy for the Sampling of Peripheral Lung Nodules
Primary Purpose
Non-small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Electromagnetic Navigation Bronchoscopy
Transthoracic Needle Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-small Cell Lung Cancer focused on measuring Lung cancer biopsy, Electromagnetic Navigation Bronchoscopy, Transthoracic Needle Biopsy
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Lung lesion requiring biopsy and amenable to Electromagnetic Navigation Bronchoscopy as determined by a "bronchus sign" on computed tomography
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electromagnetic Navigation Bronchoscopy
Transthoracic Needle Biopsy
Arm Description
Outcomes
Primary Outcome Measures
Feasibility to conduct a subsequent, large-scale Phase III randomized controlled trial.
Secondary Outcome Measures
Diagnostic yield rate
rate of conclusive pathological diagnosis
Complication rates
Number of complications, e.g. pneumothorax, hemoptysis, infection, hemothorax, air embolism.
Difference in wait times between Electromagnetic Navigation Bronchoscopy and Transthoracic Needle Biopsy
Wait time from date of biopsy request to biopsy procedure
Difference in cost between the Electromagnetic Navigation Bronchoscopy and Transthoracic Needle Biopsy as measured by the costs associated with each type of biopsy procedure
Quality of life
EQ-5D-5L
Pain assessment
Numeric Pain Rating Scale
Full Information
NCT ID
NCT02651506
First Posted
January 7, 2016
Last Updated
May 10, 2016
Sponsor
St. Joseph's Healthcare Hamilton
1. Study Identification
Unique Protocol Identification Number
NCT02651506
Brief Title
Electromagnetic Navigational Bronchoscopy Vs. Transthoracic Needle Biopsy for the Sampling of Peripheral Lung Nodules
Official Title
Navigational Bronchoscopy Vs. Transthoracic Needle Biopsy for the Sampling of Peripheral Lung Nodules: Comparison of Outcomes and Costs in a Public Healthcare System
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The use of computed tomography (CT) screening has allowed for early detection of lung cancers as small as 5mm in diameter. Early stage cancers are highly curable with a reported survival of greater than 90% over 5 years after surgical resection. Before a patient can have surgery, a biopsy must be performed. One common method is a transthoracic needle biopsy (TTNB). In this procedure, a CT-image is used to locate the area for biopsy. Once identified, the radiologist applies a local anesthetic and inserts an aspiration needle through the ribs, and into the lung tissue. The sampled lung tissue is then sent to pathology. Although this procedure has a diagnostic yield ranging between 70% and 85%, it is associated with serious complications such as pneumothorax, hemoptysis, infection, hemothorax, air embolism and there is about a 20% (range 9%-54%) incidence of pneumothorax, or air leak from the lung, requiring chest tube drainage. Additionally, about 5-15% of cases experience hemoptysis, or coughing blood, although significant life-threatening hemoptysis is only present in less than 1% of patients. When these complications occur, hospitalization as inpatients is required, with an average length of stay of 1-3 days.
A new form of technology to localize and biopsy peripheral lung lesions is believed to significantly reduce the amount of complications that can occur during a biopsy. This technology is known as Electromagnetic Navigation Bronchoscopy (ENB). ENB uses electromagnetic tracking and CT-generated virtual bronchoscopy to create a three-dimensional "GPS map" of the lung, guiding the surgeon directly to the tumor. The surgeon is then able to perform bronchoscopy and biopsy the tumor from inside the bronchus. A recent systematic review and meta-analysis of 15 trials reports a pneumothorax rate of 3.1%, with only 1.6% of patients requiring chest tube drainage. Initial studies demonstrate a slightly lower diagnostic yield for ENB as compared to TTNB; however, a systematic exploration of study heterogeneity reveal that lung nodules included in TTNB studies are larger than those included in the meta-analysis of ENB yield. The review further identified six variables associated with increased diagnostic yields for ENB, including "combined use of an ultrasonic radial probe and catheter suctioning as a sampling technique". The superDimension® InReach™ System was granted Health Canada approval on July 23, 2009.
There have been no studies directly comparing ENB to TTNB, either retrospectively or prospectively. Initial systematic reviews demonstrate that ENB may have a slightly lower diagnostic yield relative to TTNB. Selection bias and low study quality may have resulted in an underestimation of the true diagnostic yield associated with ENB. The literature also confirms that ENB has a significantly better safety profile as compared to TTNB. As such, a prospective comparison between the two techniques is mandated. This Phase II pilot feasibility trial will utilize randomized methodology to gather the preliminary data that is required for the successful completion of a Phase III randomized controlled trial to compare lung biopsy with ENB verses TTNB. This study will also be the first time ENB lung biopsy is documented in Canada.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Lung cancer biopsy, Electromagnetic Navigation Bronchoscopy, Transthoracic Needle Biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electromagnetic Navigation Bronchoscopy
Arm Type
Experimental
Arm Title
Transthoracic Needle Biopsy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Electromagnetic Navigation Bronchoscopy
Intervention Description
• Participants randomized to the intervention arm will undergo biopsy using the superDimension®InReach™ System. Participants will undergo ENB guided biopsy under general anesthesia or local anesthesia. The procedure will be performed by a thoracic surgeon in the operating room or endoscopy suite. Following electromagnetic mapping, bronchoscopy and biopsy will be performed. Fiducial markings will be placed when necessary.
Intervention Type
Procedure
Intervention Name(s)
Transthoracic Needle Biopsy
Intervention Description
• Patients randomized to the control arm (TTNB) will undergo lung biopsy using standard transthoracic needle biopsy technique. The procedure will be performed under local anesthesia with computed tomography guidance by an interventional radiologist. In this procedure, a CT-image is used to locate the area for biopsy. Once identified, the radiologist applies a local anesthetic and inserts an aspiration needle between the ribs, through normal lung tissue, leading into the biopsy area. The sampled lung tissue is then sent for pathological analysis.
Primary Outcome Measure Information:
Title
Feasibility to conduct a subsequent, large-scale Phase III randomized controlled trial.
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Diagnostic yield rate
Description
rate of conclusive pathological diagnosis
Time Frame
Through study completion, an average of 2 years
Title
Complication rates
Description
Number of complications, e.g. pneumothorax, hemoptysis, infection, hemothorax, air embolism.
Time Frame
Through study completion, an average of 2 years
Title
Difference in wait times between Electromagnetic Navigation Bronchoscopy and Transthoracic Needle Biopsy
Description
Wait time from date of biopsy request to biopsy procedure
Time Frame
Through study completion, an average of 2 years
Title
Difference in cost between the Electromagnetic Navigation Bronchoscopy and Transthoracic Needle Biopsy as measured by the costs associated with each type of biopsy procedure
Time Frame
Through study completion, an average of 2 years
Title
Quality of life
Description
EQ-5D-5L
Time Frame
Through study completion, an average of 2 years
Title
Pain assessment
Description
Numeric Pain Rating Scale
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Lung lesion requiring biopsy and amenable to Electromagnetic Navigation Bronchoscopy as determined by a "bronchus sign" on computed tomography
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waël c Hanna, MDCM, MBA, FRCSC
Organizational Affiliation
St. Joseph's Healthcare Hamilton / McMaster University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Electromagnetic Navigational Bronchoscopy Vs. Transthoracic Needle Biopsy for the Sampling of Peripheral Lung Nodules
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