CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy

Study Overview
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Brief Summary
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The purpose of this study was to compare the safety and efficacy of CT-guided needle guidance using stereotaxic unit, navigation versus conventional biopsy technique for the patients scheduled to undergo percutaneous pulmonary nodule biopsy.

Official Title
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A Single-center, Randomized, Active-controlled and Evaluator-blind Investigator-initiated Trial to Evaluate and Compare the Efficacy and Safety of CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Patients Scheduled to Undergo Percutaneous Pulmonary Nodule Biopsy

Conditions
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Percutaneous Pulmonary Nodule Biopsy

Intervention / Treatment
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* Device: stereotaxic unit, navigation
* Device: conventional biopsy technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with localized lesions such as pulmonary nodules on chest x-ray, CT or PET CT Histopathologic examination is necessary if lung lesion is unknown Histologic findings affect the disease stage or treatment plan If the investigator decides to perform a percutaneous lung biopsy because the biopsy or diagnosis through the bronchoscopy is not possible or has low risk-benefit Patient who have consented to contraception during the period of clinical trial participation (one month after the procedure) Patient who voluntarily agree to participate in this clinical trial and are willing to comply with the protocol Exclusion Criteria: Patient with pulmonary function insufficiency Patient who has difficulty in self-breathing (e.g, breathing through oxygen breathing apparatus) Patient with Uncontrolled coagulation disorders (INR > 1.3 or Blood platelet count < 50,000/µl) Patient with allergy to CT contrast agent Patient under 19 years old or over 80 years old Pregnant or lactating Patient with uncontrollable systemic disease (e.g, uncontrolled hypertension, uncontrolled cardiovascular disease, etc.) Patient who currently participating or has participated in other clinical trials within 30 days of the screening date If it is judged inappropriate to participate in this clinical trial under the judgment of the investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotaxic unit, navigation<br> | Device: stereotaxic unit, navigation<br>* CT-guided needle guidance using stereotaxic unit, navigation<br>|
| Active Comparator: Conventional biopsy technique<br> | Device: conventional biopsy technique<br>* CT-guided needle guidance using conventional biopsy technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle guide accuracy(mm) | 3D distance between target point and actual needle tip | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle guide angle deviation(°) | The angle deviation between the needle insertion path on the procedure plan and the path of the actually inserted needle | 1 day | 
| Number of needle readjustments | Retract the inserted needle and adjust the direction | 1 day | 
| Number of needle reinsertion | Needle is completely pulled out and then inserted again | 1 day | 
| Needle insertion time(min) | Time from pre-CT scan to the last CT scan before lung biopsy | 1 day | 
| Procedure time(min) | Time from pre-CT scan to dressing after lung biopsy | 1 day |